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FDA expands dasatinib indication to children with Ph+ ALL
The .
The tyrosine kinase inhibitor is now approved for use in combination with chemotherapy to treat pediatric patients aged 1 year and older who have newly diagnosed, Philadelphia-chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
Dasatinib is already approved for use in children aged 1 year and older who have chronic phase, Ph+ chronic myeloid leukemia (CML).
In adults, dasatinib is approved to treat newly diagnosed, Ph+, chronic phase CML; chronic, accelerated, or myeloid/lymphoid blast phase, Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ ALL with resistance or intolerance to prior therapy. The approval in children with Ph+ ALL is based on data from a phase 2 study (CA180-372, NCT01460160).
In this trial, researchers evaluated dasatinib in combination with the AIEOP-BFM ALL 2000 multi-agent chemotherapy protocol in patients (aged 1-17 years) with newly diagnosed, B-cell precursor, Ph+ ALL.
There were 78 patients evaluated for efficacy in cohort 1. They received dasatinib at a daily dose of 60 mg/m2 for up to 24 months.
Patients with central nervous system 3 disease received cranial irradiation, and patients were assigned to stem cell transplant based on minimal residual disease if they were thought to have a high risk of relapse.
The 3-year event-free survival rate in the 78 patients was 64.1%.
There were 81 patients evaluable for safety who received dasatinib continuously in combination with chemotherapy. Their median duration of treatment was 24 months.
The most common adverse events (AEs) in these patients were mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, and constipation.
Eight patients (10%) had AEs leading to treatment discontinuation. These included fungal sepsis, hepatotoxicity in the setting of graft-versus-host disease, thrombocytopenia, cytomegalovirus infection, pneumonia, nausea, enteritis, and drug hypersensitivity.
Three patients (4%) had fatal AEs, all infections.
This trial was sponsored by Bristol-Myers Squibb. Additional data are available in the prescribing information for dasatinib.
The .
The tyrosine kinase inhibitor is now approved for use in combination with chemotherapy to treat pediatric patients aged 1 year and older who have newly diagnosed, Philadelphia-chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
Dasatinib is already approved for use in children aged 1 year and older who have chronic phase, Ph+ chronic myeloid leukemia (CML).
In adults, dasatinib is approved to treat newly diagnosed, Ph+, chronic phase CML; chronic, accelerated, or myeloid/lymphoid blast phase, Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ ALL with resistance or intolerance to prior therapy. The approval in children with Ph+ ALL is based on data from a phase 2 study (CA180-372, NCT01460160).
In this trial, researchers evaluated dasatinib in combination with the AIEOP-BFM ALL 2000 multi-agent chemotherapy protocol in patients (aged 1-17 years) with newly diagnosed, B-cell precursor, Ph+ ALL.
There were 78 patients evaluated for efficacy in cohort 1. They received dasatinib at a daily dose of 60 mg/m2 for up to 24 months.
Patients with central nervous system 3 disease received cranial irradiation, and patients were assigned to stem cell transplant based on minimal residual disease if they were thought to have a high risk of relapse.
The 3-year event-free survival rate in the 78 patients was 64.1%.
There were 81 patients evaluable for safety who received dasatinib continuously in combination with chemotherapy. Their median duration of treatment was 24 months.
The most common adverse events (AEs) in these patients were mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, and constipation.
Eight patients (10%) had AEs leading to treatment discontinuation. These included fungal sepsis, hepatotoxicity in the setting of graft-versus-host disease, thrombocytopenia, cytomegalovirus infection, pneumonia, nausea, enteritis, and drug hypersensitivity.
Three patients (4%) had fatal AEs, all infections.
This trial was sponsored by Bristol-Myers Squibb. Additional data are available in the prescribing information for dasatinib.
The .
The tyrosine kinase inhibitor is now approved for use in combination with chemotherapy to treat pediatric patients aged 1 year and older who have newly diagnosed, Philadelphia-chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
Dasatinib is already approved for use in children aged 1 year and older who have chronic phase, Ph+ chronic myeloid leukemia (CML).
In adults, dasatinib is approved to treat newly diagnosed, Ph+, chronic phase CML; chronic, accelerated, or myeloid/lymphoid blast phase, Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Ph+ ALL with resistance or intolerance to prior therapy. The approval in children with Ph+ ALL is based on data from a phase 2 study (CA180-372, NCT01460160).
In this trial, researchers evaluated dasatinib in combination with the AIEOP-BFM ALL 2000 multi-agent chemotherapy protocol in patients (aged 1-17 years) with newly diagnosed, B-cell precursor, Ph+ ALL.
There were 78 patients evaluated for efficacy in cohort 1. They received dasatinib at a daily dose of 60 mg/m2 for up to 24 months.
Patients with central nervous system 3 disease received cranial irradiation, and patients were assigned to stem cell transplant based on minimal residual disease if they were thought to have a high risk of relapse.
The 3-year event-free survival rate in the 78 patients was 64.1%.
There were 81 patients evaluable for safety who received dasatinib continuously in combination with chemotherapy. Their median duration of treatment was 24 months.
The most common adverse events (AEs) in these patients were mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, and constipation.
Eight patients (10%) had AEs leading to treatment discontinuation. These included fungal sepsis, hepatotoxicity in the setting of graft-versus-host disease, thrombocytopenia, cytomegalovirus infection, pneumonia, nausea, enteritis, and drug hypersensitivity.
Three patients (4%) had fatal AEs, all infections.
This trial was sponsored by Bristol-Myers Squibb. Additional data are available in the prescribing information for dasatinib.
FDA expands Essure’s postmarketing surveillance study
The study, ordered in 2016, will now run 5 years instead of 3, and the cohort will be enlarged to add any women who elect implantation while the device is still on the market, FDA Commissioner Scott Gottlieb, MD, announced in a press statement. The agency also added a key biological measure: All patients with Essure will undergo regular blood work to evaluate proinflammatory markers that could be device related.
“We’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation,” Dr. Gottlieb said. “This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.”
The device has been associated with severe problems in some patients, he noted.
“I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.”
The study expansion comes as Bayer is facing more than 16,000 lawsuits over adverse events associated with Essure implantation.
Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide. Bayer claims the device is 99% effective in preventing pregnancy, but it’s also been associated with some serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. In view of these – and more than 15,000 adverse events reported to the FDA – the agency announced new restrictions on Essure earlier this year. Those restrictions, plus a prior boxed warning on the label, contributed to about a 70% decline in U.S. sales, which Bayer says prompted the discontinuation.
The open-label prospective observational study will compare women who have the Essure device to a matched cohort that underwent laparoscopic tubal ligation. The main safety endpoints are chronic pelvic pain and abnormal uterine bleeding, as well as the new measure of inflammatory markers. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm).
Women who have the implant now and remain free of any adverse events should probably keep the device, Dr. Gottlieb advised.
“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.”
The study, ordered in 2016, will now run 5 years instead of 3, and the cohort will be enlarged to add any women who elect implantation while the device is still on the market, FDA Commissioner Scott Gottlieb, MD, announced in a press statement. The agency also added a key biological measure: All patients with Essure will undergo regular blood work to evaluate proinflammatory markers that could be device related.
“We’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation,” Dr. Gottlieb said. “This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.”
The device has been associated with severe problems in some patients, he noted.
“I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.”
The study expansion comes as Bayer is facing more than 16,000 lawsuits over adverse events associated with Essure implantation.
Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide. Bayer claims the device is 99% effective in preventing pregnancy, but it’s also been associated with some serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. In view of these – and more than 15,000 adverse events reported to the FDA – the agency announced new restrictions on Essure earlier this year. Those restrictions, plus a prior boxed warning on the label, contributed to about a 70% decline in U.S. sales, which Bayer says prompted the discontinuation.
The open-label prospective observational study will compare women who have the Essure device to a matched cohort that underwent laparoscopic tubal ligation. The main safety endpoints are chronic pelvic pain and abnormal uterine bleeding, as well as the new measure of inflammatory markers. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm).
Women who have the implant now and remain free of any adverse events should probably keep the device, Dr. Gottlieb advised.
“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.”
The study, ordered in 2016, will now run 5 years instead of 3, and the cohort will be enlarged to add any women who elect implantation while the device is still on the market, FDA Commissioner Scott Gottlieb, MD, announced in a press statement. The agency also added a key biological measure: All patients with Essure will undergo regular blood work to evaluate proinflammatory markers that could be device related.
“We’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation,” Dr. Gottlieb said. “This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.”
The device has been associated with severe problems in some patients, he noted.
“I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.”
The study expansion comes as Bayer is facing more than 16,000 lawsuits over adverse events associated with Essure implantation.
Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide. Bayer claims the device is 99% effective in preventing pregnancy, but it’s also been associated with some serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. In view of these – and more than 15,000 adverse events reported to the FDA – the agency announced new restrictions on Essure earlier this year. Those restrictions, plus a prior boxed warning on the label, contributed to about a 70% decline in U.S. sales, which Bayer says prompted the discontinuation.
The open-label prospective observational study will compare women who have the Essure device to a matched cohort that underwent laparoscopic tubal ligation. The main safety endpoints are chronic pelvic pain and abnormal uterine bleeding, as well as the new measure of inflammatory markers. As of Dec. 3, 791 patients have been enrolled (293 in the Essure arm and 498 in the laparoscopic tubal ligation arm).
Women who have the implant now and remain free of any adverse events should probably keep the device, Dr. Gottlieb advised.
“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.”
With hemp now legal, FDA reaffirms rules for cannabis compounds
The newly enacted Agriculture Improvement Act of 2018 legalizes hemp production and use, but the Food and Drug Administration’s regulation of cannabis and cannabis-derived products remains unchanged.
The act (H.R. 2) revamps federal authorities’ regulatory approach to hemp production. The law removes hemp from the Controlled Substances Act, which means it is no longer an illegal substance. Hemp is now defined as cannabis and derivatives of cannabis that have extremely low concentrations (less than 0.3%, on a dry weight basis) of the psychoactive compound delta-9-tetrahydrocannabinol (THC).
Despite hemp’s new legal status, FDA Commissioner Scott Gottlieb, MD, said the FDA’s regulation of cannabis and cannabis-derived products remains the same.
“In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products,” FDA Commissioner Scott Gottlieb, MD, said in a Dec. 20 statement published on the FDA website. That means “they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
The regulation of those products will be the same regardless of the source of the substance, including from plants classified as hemp. The FDA will require cannabis and cannabis-derived products to undergo testing similar to other drug products, given the concern regarding medical claims made about those products.
“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs,” Dr. Gottlieb explained. And they “must go through the FDA drug approval process for human or animal use before they are marketed in the United States.”
Selling unapproved products with unsubstantiated claims is a “violation of the law.”
In addition, “it’s unlawful under the [Food, Drug & Cosmetics Act] to introduce food containing added CBD [cannabidiol] or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp derived,” Dr. Gottlieb noted. That’s because both CBD and THC are active ingredients in FDA-approved drugs.
Commissioner Gottlieb also noted that “pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement.” The FDA announced plans for a future meeting to discuss the lawful marketing of hemp-derived foods that do not contain CBD or THC.
The newly enacted Agriculture Improvement Act of 2018 legalizes hemp production and use, but the Food and Drug Administration’s regulation of cannabis and cannabis-derived products remains unchanged.
The act (H.R. 2) revamps federal authorities’ regulatory approach to hemp production. The law removes hemp from the Controlled Substances Act, which means it is no longer an illegal substance. Hemp is now defined as cannabis and derivatives of cannabis that have extremely low concentrations (less than 0.3%, on a dry weight basis) of the psychoactive compound delta-9-tetrahydrocannabinol (THC).
Despite hemp’s new legal status, FDA Commissioner Scott Gottlieb, MD, said the FDA’s regulation of cannabis and cannabis-derived products remains the same.
“In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products,” FDA Commissioner Scott Gottlieb, MD, said in a Dec. 20 statement published on the FDA website. That means “they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
The regulation of those products will be the same regardless of the source of the substance, including from plants classified as hemp. The FDA will require cannabis and cannabis-derived products to undergo testing similar to other drug products, given the concern regarding medical claims made about those products.
“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs,” Dr. Gottlieb explained. And they “must go through the FDA drug approval process for human or animal use before they are marketed in the United States.”
Selling unapproved products with unsubstantiated claims is a “violation of the law.”
In addition, “it’s unlawful under the [Food, Drug & Cosmetics Act] to introduce food containing added CBD [cannabidiol] or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp derived,” Dr. Gottlieb noted. That’s because both CBD and THC are active ingredients in FDA-approved drugs.
Commissioner Gottlieb also noted that “pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement.” The FDA announced plans for a future meeting to discuss the lawful marketing of hemp-derived foods that do not contain CBD or THC.
The newly enacted Agriculture Improvement Act of 2018 legalizes hemp production and use, but the Food and Drug Administration’s regulation of cannabis and cannabis-derived products remains unchanged.
The act (H.R. 2) revamps federal authorities’ regulatory approach to hemp production. The law removes hemp from the Controlled Substances Act, which means it is no longer an illegal substance. Hemp is now defined as cannabis and derivatives of cannabis that have extremely low concentrations (less than 0.3%, on a dry weight basis) of the psychoactive compound delta-9-tetrahydrocannabinol (THC).
Despite hemp’s new legal status, FDA Commissioner Scott Gottlieb, MD, said the FDA’s regulation of cannabis and cannabis-derived products remains the same.
“In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products,” FDA Commissioner Scott Gottlieb, MD, said in a Dec. 20 statement published on the FDA website. That means “they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
The regulation of those products will be the same regardless of the source of the substance, including from plants classified as hemp. The FDA will require cannabis and cannabis-derived products to undergo testing similar to other drug products, given the concern regarding medical claims made about those products.
“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs,” Dr. Gottlieb explained. And they “must go through the FDA drug approval process for human or animal use before they are marketed in the United States.”
Selling unapproved products with unsubstantiated claims is a “violation of the law.”
In addition, “it’s unlawful under the [Food, Drug & Cosmetics Act] to introduce food containing added CBD [cannabidiol] or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp derived,” Dr. Gottlieb noted. That’s because both CBD and THC are active ingredients in FDA-approved drugs.
Commissioner Gottlieb also noted that “pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement.” The FDA announced plans for a future meeting to discuss the lawful marketing of hemp-derived foods that do not contain CBD or THC.
FDA approves ravulizumab for treatment of paroxysmal nocturnal hemoglobinuria
The Food and Drug Administration has approved ravulizumab (Ultomiris) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
“The approval of Ultomiris will change the way that patients with PNH are treated. Prior to this approval, the only approved therapy for PNH required treatment every 2 weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every 8 weeks, without compromising efficacy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release from the agency.
Patients with PNH, a rare disorder, lack a protein which protects red blood cells from being destroyed in the immune system. Episodes can be triggered by stresses on the body such as infection or physical exertion, and symptoms include severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark-colored urine, kidney disease, or recurrent pain.
FDA approval for ravulizumab is based on results from a pair of clinical trials. In the first, 246 treatment-naive PNH patients received either ravulizumab or eculizumab, the current standard of care; ravulizumab was noninferior, with no patients undergoing a transfusion and all patients having similar incidence of hemolysis. In the second trial, 195 patients who had clinically stable PNH after receiving eculizumab for 6 months were randomized to receive ravulizumab or continue eculizumab; again, ravulizumab was noninferior.
The most common adverse events associated with ravulizumab were headache and respiratory tract infection. Caution is recommended when prescribing ravulizumab to patients with any type of infection.
Find the full press release on the FDA website.
The Food and Drug Administration has approved ravulizumab (Ultomiris) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
“The approval of Ultomiris will change the way that patients with PNH are treated. Prior to this approval, the only approved therapy for PNH required treatment every 2 weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every 8 weeks, without compromising efficacy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release from the agency.
Patients with PNH, a rare disorder, lack a protein which protects red blood cells from being destroyed in the immune system. Episodes can be triggered by stresses on the body such as infection or physical exertion, and symptoms include severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark-colored urine, kidney disease, or recurrent pain.
FDA approval for ravulizumab is based on results from a pair of clinical trials. In the first, 246 treatment-naive PNH patients received either ravulizumab or eculizumab, the current standard of care; ravulizumab was noninferior, with no patients undergoing a transfusion and all patients having similar incidence of hemolysis. In the second trial, 195 patients who had clinically stable PNH after receiving eculizumab for 6 months were randomized to receive ravulizumab or continue eculizumab; again, ravulizumab was noninferior.
The most common adverse events associated with ravulizumab were headache and respiratory tract infection. Caution is recommended when prescribing ravulizumab to patients with any type of infection.
Find the full press release on the FDA website.
The Food and Drug Administration has approved ravulizumab (Ultomiris) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
“The approval of Ultomiris will change the way that patients with PNH are treated. Prior to this approval, the only approved therapy for PNH required treatment every 2 weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every 8 weeks, without compromising efficacy,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release from the agency.
Patients with PNH, a rare disorder, lack a protein which protects red blood cells from being destroyed in the immune system. Episodes can be triggered by stresses on the body such as infection or physical exertion, and symptoms include severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark-colored urine, kidney disease, or recurrent pain.
FDA approval for ravulizumab is based on results from a pair of clinical trials. In the first, 246 treatment-naive PNH patients received either ravulizumab or eculizumab, the current standard of care; ravulizumab was noninferior, with no patients undergoing a transfusion and all patients having similar incidence of hemolysis. In the second trial, 195 patients who had clinically stable PNH after receiving eculizumab for 6 months were randomized to receive ravulizumab or continue eculizumab; again, ravulizumab was noninferior.
The most common adverse events associated with ravulizumab were headache and respiratory tract infection. Caution is recommended when prescribing ravulizumab to patients with any type of infection.
Find the full press release on the FDA website.
FDA reclassifies ECT devices for resistant depression, other conditions
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
FDA approves Elzonris for blastic plasmacytoid dendritic cell neoplasm
The Food and Drug Administration has approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients, 2 years of age and older.
Approval was based on efficacy in two cohorts of patients in a single-arm clinical trial. Seven patients (54%) out of 13 with untreated BPDCN achieved complete remission (CR) or CR with a skin abnormality not indicative of active disease (CRc) in the first cohort. In the second cohort of 15 patients, one patient achieved CR and one patient achieved CRc.
Common side effects for patients receiving tagraxofusp-erzs infusion were capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, chills, and weight increase. Most common laboratory abnormalities were decreases in lymphocytes, albumin, platelets, hemoglobin, and calcium, and increases in glucose and liver enzymes (ALT and AST), the FDA said in a press statement.
The FDA placed a Boxed Warning on the drug to alert health care professionals and patients about the increased risk of capillary leak syndrome and recommends that health care providers monitor liver enzyme levels for signs of intolerance to the infusion.
BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin. It often presents as leukemia or evolves into acute leukemia, the FDA said.
“Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
The Food and Drug Administration has approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients, 2 years of age and older.
Approval was based on efficacy in two cohorts of patients in a single-arm clinical trial. Seven patients (54%) out of 13 with untreated BPDCN achieved complete remission (CR) or CR with a skin abnormality not indicative of active disease (CRc) in the first cohort. In the second cohort of 15 patients, one patient achieved CR and one patient achieved CRc.
Common side effects for patients receiving tagraxofusp-erzs infusion were capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, chills, and weight increase. Most common laboratory abnormalities were decreases in lymphocytes, albumin, platelets, hemoglobin, and calcium, and increases in glucose and liver enzymes (ALT and AST), the FDA said in a press statement.
The FDA placed a Boxed Warning on the drug to alert health care professionals and patients about the increased risk of capillary leak syndrome and recommends that health care providers monitor liver enzyme levels for signs of intolerance to the infusion.
BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin. It often presents as leukemia or evolves into acute leukemia, the FDA said.
“Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
The Food and Drug Administration has approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients, 2 years of age and older.
Approval was based on efficacy in two cohorts of patients in a single-arm clinical trial. Seven patients (54%) out of 13 with untreated BPDCN achieved complete remission (CR) or CR with a skin abnormality not indicative of active disease (CRc) in the first cohort. In the second cohort of 15 patients, one patient achieved CR and one patient achieved CRc.
Common side effects for patients receiving tagraxofusp-erzs infusion were capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, chills, and weight increase. Most common laboratory abnormalities were decreases in lymphocytes, albumin, platelets, hemoglobin, and calcium, and increases in glucose and liver enzymes (ALT and AST), the FDA said in a press statement.
The FDA placed a Boxed Warning on the drug to alert health care professionals and patients about the increased risk of capillary leak syndrome and recommends that health care providers monitor liver enzyme levels for signs of intolerance to the infusion.
BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin. It often presents as leukemia or evolves into acute leukemia, the FDA said.
“Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
FDA approves olaparib for maintenance treatment of BRCA-mutated advanced ovarian cancer
The Food and Drug Administration has approved olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy.
The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories) to identify patients who are eligible for olaparib.
Approval of olaparib was based on improvement in progression-free survival (PFS) in the phase 3 SOLO-1 trial of 391 women with BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line, platinum-based chemotherapy. Patients were randomized (2:1) to receive olaparib tablets 300 mg orally twice daily or placebo.
Estimated median investigator-assessed PFS was not reached in the olaparib arm and was 13.8 months in the placebo arm (hazard ratio, 0.30; 95% confidence interval, 0.23-0.41; P less than .0001). Overall survival data are not yet mature.
The most common adverse reactions in women who received olaparib in SOLO-1 were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.
The recommended olaparib dose is 300 mg (two 150 mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg, the FDA said in a press statement.
Olaparib is marketed as Lynparza by AstraZeneca Pharmaceuticals.
The Food and Drug Administration has approved olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy.
The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories) to identify patients who are eligible for olaparib.
Approval of olaparib was based on improvement in progression-free survival (PFS) in the phase 3 SOLO-1 trial of 391 women with BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line, platinum-based chemotherapy. Patients were randomized (2:1) to receive olaparib tablets 300 mg orally twice daily or placebo.
Estimated median investigator-assessed PFS was not reached in the olaparib arm and was 13.8 months in the placebo arm (hazard ratio, 0.30; 95% confidence interval, 0.23-0.41; P less than .0001). Overall survival data are not yet mature.
The most common adverse reactions in women who received olaparib in SOLO-1 were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.
The recommended olaparib dose is 300 mg (two 150 mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg, the FDA said in a press statement.
Olaparib is marketed as Lynparza by AstraZeneca Pharmaceuticals.
The Food and Drug Administration has approved olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy.
The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories) to identify patients who are eligible for olaparib.
Approval of olaparib was based on improvement in progression-free survival (PFS) in the phase 3 SOLO-1 trial of 391 women with BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer following first-line, platinum-based chemotherapy. Patients were randomized (2:1) to receive olaparib tablets 300 mg orally twice daily or placebo.
Estimated median investigator-assessed PFS was not reached in the olaparib arm and was 13.8 months in the placebo arm (hazard ratio, 0.30; 95% confidence interval, 0.23-0.41; P less than .0001). Overall survival data are not yet mature.
The most common adverse reactions in women who received olaparib in SOLO-1 were nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia, and stomatitis.
The recommended olaparib dose is 300 mg (two 150 mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg, the FDA said in a press statement.
Olaparib is marketed as Lynparza by AstraZeneca Pharmaceuticals.
Deadly Marburg virus found in West Africa
Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.
Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.
While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.
“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.
The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.
The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.
Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.
Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.
Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.
Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).
“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.
The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.
SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).
Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.
Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.
While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.
“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.
The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.
The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.
Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.
Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.
Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.
Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).
“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.
The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.
SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).
Marburg virus has been found in fruit bats in Sierra Leone, marking the first appearance of the deadly, Ebola-like virus in West Africa, the Centers for Disease Control and Prevention (CDC) is reporting.
Five Egyptian rousette fruit bats found in three different districts tested positive for infection with Marburg virus, a cousin to Ebola that can cause a hemorrhagic fever with case fatality rates up to 90%, according to CDC.
While no confirmed cases of Marburg infection have been reported in Sierra Leone, the presence of virus in these bats indicates that people nearby may be at risk, according to scientists.
“We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa, so it’s not surprising that we’d find the virus in bats there,” CDC ecologist Jonathan S. Towner, PhD, said in a news release.
The Egyptian rousette bat (Rousettus aegyptiacus) is the natural reservoir for Marburg, shedding the virus in saliva, urine, and feces while feeding on fruit. People and are exposed to the virus when they eat contaminated fruit or capture bats for food, according to the CDC.
The most recent Marburg virus outbreak, which occurred in Uganda in 2017, was the 12th reported outbreak linked to Africa, according to the agency. The largest and deadliest outbreak occurred in 2005 in Angola, infecting 252 people, of whom 90% died.
Testing of the Marburg-positive bats revealed genetically diverse strains, suggesting the virus has been present in Sierra Leone bat colonies for many years, the agency said. Two of the four Marburg virus strains identified in the Sierra Leone bats were genetically similar to the strain implicated in the Angola outbreak.
Egyptian fruit bats are in fact common throughout Africa, living in caves or underground mines. Marburg-positive bats have been found in sub-Saharan Africa, according to researchers, mainly in Uganda and the Democratic Republic of Congo.
Colonies of Egyptian fruit bats can number more than 100,000 animals in eastern and central Africa, while in Sierra Leone, colonies are much smaller, which may explain the lack of Marburg virus disease outbreaks in that country, CDC said.
Discovery of Marburg virus in Sierra Leone was the result of two projects, one led by the CDC and Njala University in Freetown, Sierra Leone, and the other by the University of California, Davis, and the University of Makeni, Sierra Leone, which was funded by the United States Agency for International Development (USAID).
“This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick.” Dr. Towner said in the news release.
The two projects began in 2016 after the large Ebola outbreak in West Africa with the aim of identifying the reservoir of Ebola, according to CDC.
SOURCES: U.S. Department of Health and Human Services CDC Newsroom and Centers for Disease Control and Prevention (Marburg Virus).
FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION
Pembrolizumab approved for Merkel cell carcinoma
The Food and Drug Administration has , specifically for recurrent locally advanced or metastatic disease.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached. But responses lasting more than 6 months were achieved by 96% and more than 12 months by 54%. The most common adverse reactions included fatigue, musculoskeletal pain, and decreased appetite.
Because it is an accelerated approval, “continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the FDA press release announcing the approval.
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that was previously approved for treatment of unresectable or metastatic melanoma.
More about the latest approval, as well as full prescribing information, can be found on the FDA’s website.
The Food and Drug Administration has , specifically for recurrent locally advanced or metastatic disease.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached. But responses lasting more than 6 months were achieved by 96% and more than 12 months by 54%. The most common adverse reactions included fatigue, musculoskeletal pain, and decreased appetite.
Because it is an accelerated approval, “continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the FDA press release announcing the approval.
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that was previously approved for treatment of unresectable or metastatic melanoma.
More about the latest approval, as well as full prescribing information, can be found on the FDA’s website.
The Food and Drug Administration has , specifically for recurrent locally advanced or metastatic disease.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached. But responses lasting more than 6 months were achieved by 96% and more than 12 months by 54%. The most common adverse reactions included fatigue, musculoskeletal pain, and decreased appetite.
Because it is an accelerated approval, “continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the FDA press release announcing the approval.
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody that was previously approved for treatment of unresectable or metastatic melanoma.
More about the latest approval, as well as full prescribing information, can be found on the FDA’s website.
FDA aims to boost safety of platelets for transfusion
The Food and Drug Administration is asking for comments on its
The draft document, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through Feb. 4, 2019.
It is the first update to the policy document since 2016.
In the draft guidance, the FDA recommended three strategies for platelets stored for 5 days from collection. For apheresis platelets and prestorage pools, the FDA suggested an initial primary culture followed by a secondary culture on day 3 or day 4 or an initial primary culture followed by secondary testing with a rapid test. The third strategy – for apheresis platelets – is pathogen reduction alone.
The FDA also outlined three strategies for testing platelets stored for 7 days, all of which apply to apheresis platelets. The methods include an initial primary culture followed by a secondary culture no earlier than day 4, using a device labeled as a safety measure; an initial primary culture followed by a secondary rapid test, labeled as a safety measure; or large volume delayed sampling.
The supply of blood and blood components in the United States is among the safest in the world, FDA Commissioner Scott Gottlieb, MD, said in a statement. The FDA’s continuously updated protocols are intended to keep it that way.
“Blood and blood components are some of the most critical medical products American patients depend upon,” Dr. Gottlieb wrote. “But there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
Since the 2016 guidance document was issued, new strategies for bacterial detection have become available that could potentially reduce the risk of contamination of platelets and permit extension of platelet dating up to 7 days, including bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen reduction technology.
The recommendations in the draft guidance incorporate ideas put forth during a July 2018 meeting of the agency’s Blood Products Advisory Committee. Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved. Their comments have been incorporated into the new draft guidance document.
In late November 2018, the FDA held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies. “The ideal pathogen reduction technology would: be relatively inexpensive, be simple to implement on whole blood, allow treated blood to subsequently be separated into components or alternatively could be performed on apheresis products, inactivate a broad range of pathogens, and would have no adverse effect on product safety or product yield,” the FDA noted in a statement.
The Food and Drug Administration is asking for comments on its
The draft document, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through Feb. 4, 2019.
It is the first update to the policy document since 2016.
In the draft guidance, the FDA recommended three strategies for platelets stored for 5 days from collection. For apheresis platelets and prestorage pools, the FDA suggested an initial primary culture followed by a secondary culture on day 3 or day 4 or an initial primary culture followed by secondary testing with a rapid test. The third strategy – for apheresis platelets – is pathogen reduction alone.
The FDA also outlined three strategies for testing platelets stored for 7 days, all of which apply to apheresis platelets. The methods include an initial primary culture followed by a secondary culture no earlier than day 4, using a device labeled as a safety measure; an initial primary culture followed by a secondary rapid test, labeled as a safety measure; or large volume delayed sampling.
The supply of blood and blood components in the United States is among the safest in the world, FDA Commissioner Scott Gottlieb, MD, said in a statement. The FDA’s continuously updated protocols are intended to keep it that way.
“Blood and blood components are some of the most critical medical products American patients depend upon,” Dr. Gottlieb wrote. “But there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
Since the 2016 guidance document was issued, new strategies for bacterial detection have become available that could potentially reduce the risk of contamination of platelets and permit extension of platelet dating up to 7 days, including bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen reduction technology.
The recommendations in the draft guidance incorporate ideas put forth during a July 2018 meeting of the agency’s Blood Products Advisory Committee. Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved. Their comments have been incorporated into the new draft guidance document.
In late November 2018, the FDA held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies. “The ideal pathogen reduction technology would: be relatively inexpensive, be simple to implement on whole blood, allow treated blood to subsequently be separated into components or alternatively could be performed on apheresis products, inactivate a broad range of pathogens, and would have no adverse effect on product safety or product yield,” the FDA noted in a statement.
The Food and Drug Administration is asking for comments on its
The draft document, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through Feb. 4, 2019.
It is the first update to the policy document since 2016.
In the draft guidance, the FDA recommended three strategies for platelets stored for 5 days from collection. For apheresis platelets and prestorage pools, the FDA suggested an initial primary culture followed by a secondary culture on day 3 or day 4 or an initial primary culture followed by secondary testing with a rapid test. The third strategy – for apheresis platelets – is pathogen reduction alone.
The FDA also outlined three strategies for testing platelets stored for 7 days, all of which apply to apheresis platelets. The methods include an initial primary culture followed by a secondary culture no earlier than day 4, using a device labeled as a safety measure; an initial primary culture followed by a secondary rapid test, labeled as a safety measure; or large volume delayed sampling.
The supply of blood and blood components in the United States is among the safest in the world, FDA Commissioner Scott Gottlieb, MD, said in a statement. The FDA’s continuously updated protocols are intended to keep it that way.
“Blood and blood components are some of the most critical medical products American patients depend upon,” Dr. Gottlieb wrote. “But there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
Since the 2016 guidance document was issued, new strategies for bacterial detection have become available that could potentially reduce the risk of contamination of platelets and permit extension of platelet dating up to 7 days, including bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen reduction technology.
The recommendations in the draft guidance incorporate ideas put forth during a July 2018 meeting of the agency’s Blood Products Advisory Committee. Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved. Their comments have been incorporated into the new draft guidance document.
In late November 2018, the FDA held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies. “The ideal pathogen reduction technology would: be relatively inexpensive, be simple to implement on whole blood, allow treated blood to subsequently be separated into components or alternatively could be performed on apheresis products, inactivate a broad range of pathogens, and would have no adverse effect on product safety or product yield,” the FDA noted in a statement.