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FDA updates nilotinib product label outlining criteria for discontinuation
for patients who meet certain criteria. Nilotinib, a kinase inhibitor that blocks the BCR-ABL protein that promotes abnormal cell growth, was originally approved in 2007 and was indicated for use in patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). In accordance with the new label update, patients who have early phase CML, have been using nilotinib for 3 years or more, and whose leukemia has responded to treatment according to a test that has received FDA marketing authorization, may be eligible to discontinue use of nilotinib.
The information that led to the FDA approved label update was based on two single-arm trials of patients with chronic phase Ph+ CML. The trial measured the length of time patients were able to discontinue use of nilotinib without leukemia returning, and who had entered treatment-free remission (TFR). In the first trial, among 190 newly diagnosed CML patients who discontinued taking nilotinib after using the drug for 3 or more years, 51.6% were still in TFR after about 1 year (48 weeks) and 48.9% were still in TFR after nearly 2 years (96 weeks). Similar results were seen in the second trial, among 126 patients, with 57.9% in TFR after about a year (48 weeks) and 53.2% in TFR after approximately 2 years (96 weeks).
An important element of these trials was regular monitoring of specific RNA information that specifies the level of BCR-ABL protein in the blood using a diagnostic test that has received FDA marketing authorization. Monitoring with a test that accurately detects the reductions of RNA information in the blood with accuracy and precision is critical in discontinuing the use of nilotinib. This monitoring will allow physicians to detect the first signs of relapse.
“Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval shows that some patients may be able to stop treatment with Tasigna altogether if they are showing a strong response to therapy. While we welcome this progress in patient care, it’s important to note that any discontinuation of treatment still means patients must be regularly monitored for disease recurrence,” Dr. Pazdur said in the FDA statement.
Common side effects after discontinuing use of nilotinib include body aches and pain in the bones and extremities. Severe side effects of taking nilotinib can include myelosuppression, blockages in the heart and arteries, and inflammation of the pancreas. Severe liver damage can also occur.
Severe side effects typically associated with nilotinib administration occurred less frequently in patients who discontinued the drug. However, the long-term outcomes of patients discontinuing versus continuing treatment are unknown at this time, the FDA noted.
for patients who meet certain criteria. Nilotinib, a kinase inhibitor that blocks the BCR-ABL protein that promotes abnormal cell growth, was originally approved in 2007 and was indicated for use in patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). In accordance with the new label update, patients who have early phase CML, have been using nilotinib for 3 years or more, and whose leukemia has responded to treatment according to a test that has received FDA marketing authorization, may be eligible to discontinue use of nilotinib.
The information that led to the FDA approved label update was based on two single-arm trials of patients with chronic phase Ph+ CML. The trial measured the length of time patients were able to discontinue use of nilotinib without leukemia returning, and who had entered treatment-free remission (TFR). In the first trial, among 190 newly diagnosed CML patients who discontinued taking nilotinib after using the drug for 3 or more years, 51.6% were still in TFR after about 1 year (48 weeks) and 48.9% were still in TFR after nearly 2 years (96 weeks). Similar results were seen in the second trial, among 126 patients, with 57.9% in TFR after about a year (48 weeks) and 53.2% in TFR after approximately 2 years (96 weeks).
An important element of these trials was regular monitoring of specific RNA information that specifies the level of BCR-ABL protein in the blood using a diagnostic test that has received FDA marketing authorization. Monitoring with a test that accurately detects the reductions of RNA information in the blood with accuracy and precision is critical in discontinuing the use of nilotinib. This monitoring will allow physicians to detect the first signs of relapse.
“Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval shows that some patients may be able to stop treatment with Tasigna altogether if they are showing a strong response to therapy. While we welcome this progress in patient care, it’s important to note that any discontinuation of treatment still means patients must be regularly monitored for disease recurrence,” Dr. Pazdur said in the FDA statement.
Common side effects after discontinuing use of nilotinib include body aches and pain in the bones and extremities. Severe side effects of taking nilotinib can include myelosuppression, blockages in the heart and arteries, and inflammation of the pancreas. Severe liver damage can also occur.
Severe side effects typically associated with nilotinib administration occurred less frequently in patients who discontinued the drug. However, the long-term outcomes of patients discontinuing versus continuing treatment are unknown at this time, the FDA noted.
for patients who meet certain criteria. Nilotinib, a kinase inhibitor that blocks the BCR-ABL protein that promotes abnormal cell growth, was originally approved in 2007 and was indicated for use in patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). In accordance with the new label update, patients who have early phase CML, have been using nilotinib for 3 years or more, and whose leukemia has responded to treatment according to a test that has received FDA marketing authorization, may be eligible to discontinue use of nilotinib.
The information that led to the FDA approved label update was based on two single-arm trials of patients with chronic phase Ph+ CML. The trial measured the length of time patients were able to discontinue use of nilotinib without leukemia returning, and who had entered treatment-free remission (TFR). In the first trial, among 190 newly diagnosed CML patients who discontinued taking nilotinib after using the drug for 3 or more years, 51.6% were still in TFR after about 1 year (48 weeks) and 48.9% were still in TFR after nearly 2 years (96 weeks). Similar results were seen in the second trial, among 126 patients, with 57.9% in TFR after about a year (48 weeks) and 53.2% in TFR after approximately 2 years (96 weeks).
An important element of these trials was regular monitoring of specific RNA information that specifies the level of BCR-ABL protein in the blood using a diagnostic test that has received FDA marketing authorization. Monitoring with a test that accurately detects the reductions of RNA information in the blood with accuracy and precision is critical in discontinuing the use of nilotinib. This monitoring will allow physicians to detect the first signs of relapse.
“Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval shows that some patients may be able to stop treatment with Tasigna altogether if they are showing a strong response to therapy. While we welcome this progress in patient care, it’s important to note that any discontinuation of treatment still means patients must be regularly monitored for disease recurrence,” Dr. Pazdur said in the FDA statement.
Common side effects after discontinuing use of nilotinib include body aches and pain in the bones and extremities. Severe side effects of taking nilotinib can include myelosuppression, blockages in the heart and arteries, and inflammation of the pancreas. Severe liver damage can also occur.
Severe side effects typically associated with nilotinib administration occurred less frequently in patients who discontinued the drug. However, the long-term outcomes of patients discontinuing versus continuing treatment are unknown at this time, the FDA noted.
FDA approves hydroxyurea for pediatric patients with sickle cell anemia
to reduce the frequency of painful crises and the need for blood transfusions, the Food and Drug Administration announced on Dec. 21.
This is the first FDA approval of hydroxyurea for use in pediatric sickle cell patients. The recommended initial dose is 20 mg/kg once daily but can be changed based on blood count levels, the agency said in a press release.
The most common adverse reactions to hydroxyurea, infections and neutropenia, occurred in less than 10% of patients. Hydroxyurea causes severe myelosuppression and should not be administered to patients with depressed bone marrow function.
Hydroxyurea is manufactured as Siklos by Addmedica. More information concerning hydroxyurea indications, dosing, and precautions can be found here.
SOURCE: FDA press release.
to reduce the frequency of painful crises and the need for blood transfusions, the Food and Drug Administration announced on Dec. 21.
This is the first FDA approval of hydroxyurea for use in pediatric sickle cell patients. The recommended initial dose is 20 mg/kg once daily but can be changed based on blood count levels, the agency said in a press release.
The most common adverse reactions to hydroxyurea, infections and neutropenia, occurred in less than 10% of patients. Hydroxyurea causes severe myelosuppression and should not be administered to patients with depressed bone marrow function.
Hydroxyurea is manufactured as Siklos by Addmedica. More information concerning hydroxyurea indications, dosing, and precautions can be found here.
SOURCE: FDA press release.
to reduce the frequency of painful crises and the need for blood transfusions, the Food and Drug Administration announced on Dec. 21.
This is the first FDA approval of hydroxyurea for use in pediatric sickle cell patients. The recommended initial dose is 20 mg/kg once daily but can be changed based on blood count levels, the agency said in a press release.
The most common adverse reactions to hydroxyurea, infections and neutropenia, occurred in less than 10% of patients. Hydroxyurea causes severe myelosuppression and should not be administered to patients with depressed bone marrow function.
Hydroxyurea is manufactured as Siklos by Addmedica. More information concerning hydroxyurea indications, dosing, and precautions can be found here.
SOURCE: FDA press release.
Ertugliflozin gets FDA thumbs-up for glucose control
The Food and Drug Administration has approved ertugliflozin for use both as monotherapy and in combination with sitagliptin or metformin to control blood glucose in patients with type 2 diabetes.
The FDA approval covers ertugliflozin monotherapy (Steglatro, Merck and Pfizer) and ertugliflozin plus sitagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, as a fixed-dose combination (Steglujan, Merck) and ertugliflozin plus metformin (Segluromet, Merck).
Ertugliflozin is the third sodium glucose cotransporter 2 (SGLT2) inhibitor to win FDA approval. Another such agent, empagliflozin, recently won a second indication for lowering the risk for cardiovascular death in adults with type 2 diabetes and established heart disease.
The American Diabetes Association recognized the value of SGLT2 inhibitors in patients with type 2 diabetes in its 2018 Standards of Care in Diabetes, now recommending that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the SGLT2 inhibitor empagliflozin or the glucagonlike peptide–1 agonist liraglutide – to the regimens of patients with diabetes and atherosclerotic cardiovascular disease (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).
skubetin@frontlinemedcom.com
The Food and Drug Administration has approved ertugliflozin for use both as monotherapy and in combination with sitagliptin or metformin to control blood glucose in patients with type 2 diabetes.
The FDA approval covers ertugliflozin monotherapy (Steglatro, Merck and Pfizer) and ertugliflozin plus sitagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, as a fixed-dose combination (Steglujan, Merck) and ertugliflozin plus metformin (Segluromet, Merck).
Ertugliflozin is the third sodium glucose cotransporter 2 (SGLT2) inhibitor to win FDA approval. Another such agent, empagliflozin, recently won a second indication for lowering the risk for cardiovascular death in adults with type 2 diabetes and established heart disease.
The American Diabetes Association recognized the value of SGLT2 inhibitors in patients with type 2 diabetes in its 2018 Standards of Care in Diabetes, now recommending that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the SGLT2 inhibitor empagliflozin or the glucagonlike peptide–1 agonist liraglutide – to the regimens of patients with diabetes and atherosclerotic cardiovascular disease (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).
skubetin@frontlinemedcom.com
The Food and Drug Administration has approved ertugliflozin for use both as monotherapy and in combination with sitagliptin or metformin to control blood glucose in patients with type 2 diabetes.
The FDA approval covers ertugliflozin monotherapy (Steglatro, Merck and Pfizer) and ertugliflozin plus sitagliptin, a dipeptidyl peptidase–4 (DPP-4) inhibitor, as a fixed-dose combination (Steglujan, Merck) and ertugliflozin plus metformin (Segluromet, Merck).
Ertugliflozin is the third sodium glucose cotransporter 2 (SGLT2) inhibitor to win FDA approval. Another such agent, empagliflozin, recently won a second indication for lowering the risk for cardiovascular death in adults with type 2 diabetes and established heart disease.
The American Diabetes Association recognized the value of SGLT2 inhibitors in patients with type 2 diabetes in its 2018 Standards of Care in Diabetes, now recommending that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the SGLT2 inhibitor empagliflozin or the glucagonlike peptide–1 agonist liraglutide – to the regimens of patients with diabetes and atherosclerotic cardiovascular disease (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).
skubetin@frontlinemedcom.com
FDA okays dosing software for hemophilia A
The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.
The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.
The free, web-based software estimates a patient’s pharmokinetic curve using age, body weight, and local laboratory FVIII one-stage clotting activity measurements and allows physicians to estimate a full pharmokinetic curve with just two measurable blood samples, according to Shire, the software’s manufacturer. That’s much lower than the 9-11 blood samples recommendation from the International Society on Thrombosis and Haemostasis.
The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.
The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.
The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.
The free, web-based software estimates a patient’s pharmokinetic curve using age, body weight, and local laboratory FVIII one-stage clotting activity measurements and allows physicians to estimate a full pharmokinetic curve with just two measurable blood samples, according to Shire, the software’s manufacturer. That’s much lower than the 9-11 blood samples recommendation from the International Society on Thrombosis and Haemostasis.
The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.
The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.
The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.
The free, web-based software estimates a patient’s pharmokinetic curve using age, body weight, and local laboratory FVIII one-stage clotting activity measurements and allows physicians to estimate a full pharmokinetic curve with just two measurable blood samples, according to Shire, the software’s manufacturer. That’s much lower than the 9-11 blood samples recommendation from the International Society on Thrombosis and Haemostasis.
The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.
FDA: Gadolinium retention prompts new GBCA class warning, safety measures
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
sworcester@frontlinemedcom.com
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
sworcester@frontlinemedcom.com
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
sworcester@frontlinemedcom.com
FDA okays dosing software for hemophilia A
The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.
The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.
The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.
The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.
The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.
The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.
The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.
The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.
The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.
FDA approves cabozantinib for the frontline treatment of advanced RCC
The Food and Drug Administration has approved cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC).
The drug was approved in 2016 for patients who had received prior antiangiogenic therapy.
The expanded approval was based on improvement in progression-free survival when compared with sunitinib in the phase 2 CABOSUN trial of 157 patients with previously untreated RCC, according to a statement from the company.
Grade 3 or 4 adverse reactions were reported in 68% of patients receiving cabozantinib, compared with 65% of patients receiving sunitinib. The most frequent adverse reactions in patients treated with cabozantinib were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension, and syncope. Approximately one-fifth of patients discontinued treatment in both arms.
Cabozantinib is marketed as Cabometyx by Exelixis.
The Food and Drug Administration has approved cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC).
The drug was approved in 2016 for patients who had received prior antiangiogenic therapy.
The expanded approval was based on improvement in progression-free survival when compared with sunitinib in the phase 2 CABOSUN trial of 157 patients with previously untreated RCC, according to a statement from the company.
Grade 3 or 4 adverse reactions were reported in 68% of patients receiving cabozantinib, compared with 65% of patients receiving sunitinib. The most frequent adverse reactions in patients treated with cabozantinib were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension, and syncope. Approximately one-fifth of patients discontinued treatment in both arms.
Cabozantinib is marketed as Cabometyx by Exelixis.
The Food and Drug Administration has approved cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC).
The drug was approved in 2016 for patients who had received prior antiangiogenic therapy.
The expanded approval was based on improvement in progression-free survival when compared with sunitinib in the phase 2 CABOSUN trial of 157 patients with previously untreated RCC, according to a statement from the company.
Grade 3 or 4 adverse reactions were reported in 68% of patients receiving cabozantinib, compared with 65% of patients receiving sunitinib. The most frequent adverse reactions in patients treated with cabozantinib were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension, and syncope. Approximately one-fifth of patients discontinued treatment in both arms.
Cabozantinib is marketed as Cabometyx by Exelixis.
FDA: Gadolinium retention prompts new GBCA class warning, safety measures
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
Gadolinium-based contrast agents (GBCAs) used for MRI will now carry a warning regarding their potential retention in the bodies and brains of treated patients, according to the Food and Drug Administration.
The FDA is requiring the new class warning, along with other safety measures, based on evidence showing that trace amounts of gadolinium can be retained in the body for months to years after treatment.
Specifically, the agency will require that patients receiving GBCAs first receive a Medication Guide and that GBCA manufacturers conduct human and animal studies to further assess GBCA safety. At this time, the only known adverse health effect of gadolinium retention is nephrogenic systemic fibrosis, which affects a small subgroup of patients with pre-existing kidney failure. No causal association has been established between gadolinium retention and reported adverse events in those with normal kidney function.
The FDA recommended that health care professionals consider the retention characteristics of GBCAs for patients who may be at higher risk for retention, including those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions, but stressed that, although repeated GBCA imaging studies should be minimized when possible, they should not be avoided or deferred when they are necessary. In the safety alert, the FDA noted that administration of the GBCAs Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol) produce the lowest gadolinium levels in the body, and the three agents leave similar gadolinium levels in the body.
The agency encourages reports of adverse events or side effects related to the use of GBCAs to its MedWatch Safety information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report or by calling 1-800-332-1088 to request a preaddressed form that can be mailed or faxed to 1-800-FDA-0178.
FDA: Laparoscopic power morcellators can spread malignant cells when used in women with occult uterine cancers*
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
msullivan@frontlinemedcom.com
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
msullivan@frontlinemedcom.com
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
msullivan@frontlinemedcom.com
FDA approves Eskata for treatment of raised SKs
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.