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FDA approves IL-17A antagonist for treating psoriatic arthritis
The interleukin-17A antagonist ixekizumab has been approved by the Food and Drug Administration for treating adults with active psoriatic arthritis (PsA), based on two phase 3 studies, the manufacturer announced in a written statement Dec. 1.
The Eli Lilly statement noted that the approval is based on two randomized, double-blind, placebo-controlled studies; one compared ixekizumab to placebo in patients with active PsA never treated with a biologic (SPIRIT-P1) and another tested the drug in those who had been treated with a tumor necrosis factor inhibitor (TNFi) previously (SPIRIT-P2).
Ixekizumab, marketed as Taltz by Eli Lilly, was first approved by the FDA in 2016 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The statement did not provide information on dermatologic endpoints, but treatment with ixekizumab “resulted in an improvement in psoriatic skin lesions in patients with PsA,” as well as “in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis,” according to the prescribing information.
The recommended dose for patients with psoriatic arthritis is 160 mg by subcutaneous injection (two 80 mg injections) at baseline, followed by 80 mg every 4 weeks. When patients with psoriatic arthritis also have moderate-to-severe plaque psoriasis, then the prescribing information recommends following the dosing for psoriasis, which is 160 mg (two 80 mg injections) at baseline, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.
The most common adverse reactions associated with ixekizumab are injection site reactions, upper respiratory tract infections, nausea, and tinea infections, according to the warnings and precautions section of the drug’s prescribing information, which lists the potential for serious infections, tuberculosis, and serious allergic reactions. Prescriptions come with a Medication Guide for patients.
The interleukin-17A antagonist ixekizumab has been approved by the Food and Drug Administration for treating adults with active psoriatic arthritis (PsA), based on two phase 3 studies, the manufacturer announced in a written statement Dec. 1.
The Eli Lilly statement noted that the approval is based on two randomized, double-blind, placebo-controlled studies; one compared ixekizumab to placebo in patients with active PsA never treated with a biologic (SPIRIT-P1) and another tested the drug in those who had been treated with a tumor necrosis factor inhibitor (TNFi) previously (SPIRIT-P2).
Ixekizumab, marketed as Taltz by Eli Lilly, was first approved by the FDA in 2016 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The statement did not provide information on dermatologic endpoints, but treatment with ixekizumab “resulted in an improvement in psoriatic skin lesions in patients with PsA,” as well as “in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis,” according to the prescribing information.
The recommended dose for patients with psoriatic arthritis is 160 mg by subcutaneous injection (two 80 mg injections) at baseline, followed by 80 mg every 4 weeks. When patients with psoriatic arthritis also have moderate-to-severe plaque psoriasis, then the prescribing information recommends following the dosing for psoriasis, which is 160 mg (two 80 mg injections) at baseline, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.
The most common adverse reactions associated with ixekizumab are injection site reactions, upper respiratory tract infections, nausea, and tinea infections, according to the warnings and precautions section of the drug’s prescribing information, which lists the potential for serious infections, tuberculosis, and serious allergic reactions. Prescriptions come with a Medication Guide for patients.
The interleukin-17A antagonist ixekizumab has been approved by the Food and Drug Administration for treating adults with active psoriatic arthritis (PsA), based on two phase 3 studies, the manufacturer announced in a written statement Dec. 1.
The Eli Lilly statement noted that the approval is based on two randomized, double-blind, placebo-controlled studies; one compared ixekizumab to placebo in patients with active PsA never treated with a biologic (SPIRIT-P1) and another tested the drug in those who had been treated with a tumor necrosis factor inhibitor (TNFi) previously (SPIRIT-P2).
Ixekizumab, marketed as Taltz by Eli Lilly, was first approved by the FDA in 2016 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The statement did not provide information on dermatologic endpoints, but treatment with ixekizumab “resulted in an improvement in psoriatic skin lesions in patients with PsA,” as well as “in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis,” according to the prescribing information.
The recommended dose for patients with psoriatic arthritis is 160 mg by subcutaneous injection (two 80 mg injections) at baseline, followed by 80 mg every 4 weeks. When patients with psoriatic arthritis also have moderate-to-severe plaque psoriasis, then the prescribing information recommends following the dosing for psoriasis, which is 160 mg (two 80 mg injections) at baseline, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.
The most common adverse reactions associated with ixekizumab are injection site reactions, upper respiratory tract infections, nausea, and tinea infections, according to the warnings and precautions section of the drug’s prescribing information, which lists the potential for serious infections, tuberculosis, and serious allergic reactions. Prescriptions come with a Medication Guide for patients.
FDA approves first trastuzumab biosimilar
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with HER2+ breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
This is the first biosimilar approved in the United States for the treatment of breast cancer or gastric cancer and the second biosimilar approved for the treatment of cancer, the FDA said in a statement.
The approval of trastuzumab-dkst is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.
Common expected side effects of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Common expected side effects for the treatment of HER2+ metastatic gastric cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
The biosimilar label contains a Boxed Warning – as trastuzumab does – about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and fetal toxicity.
The FDA’s Oncologic Drugs Advisory Committee voted unanimously in July to recommend approval of the biosimilar, made by Mylan and Biocon.
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with HER2+ breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
This is the first biosimilar approved in the United States for the treatment of breast cancer or gastric cancer and the second biosimilar approved for the treatment of cancer, the FDA said in a statement.
The approval of trastuzumab-dkst is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.
Common expected side effects of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Common expected side effects for the treatment of HER2+ metastatic gastric cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
The biosimilar label contains a Boxed Warning – as trastuzumab does – about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and fetal toxicity.
The FDA’s Oncologic Drugs Advisory Committee voted unanimously in July to recommend approval of the biosimilar, made by Mylan and Biocon.
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with HER2+ breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
This is the first biosimilar approved in the United States for the treatment of breast cancer or gastric cancer and the second biosimilar approved for the treatment of cancer, the FDA said in a statement.
The approval of trastuzumab-dkst is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.
Common expected side effects of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Common expected side effects for the treatment of HER2+ metastatic gastric cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
The biosimilar label contains a Boxed Warning – as trastuzumab does – about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and fetal toxicity.
The FDA’s Oncologic Drugs Advisory Committee voted unanimously in July to recommend approval of the biosimilar, made by Mylan and Biocon.
Breakthrough cancer gene assay approved, CMS proposes coverage
The Food and Drug Administration approved a new genetic sequencing test that detects mutations across 324 genes in tumor biopsy specimens with an accuracy of 94.6%.
The FoundationOne CDx (F1CDx) test from Foundation Medicine “can identify which patients with any of five tumor types” – non–small-cell lung cancer, melanoma, breast cancer, colorectal cancer, or ovarian cancer – “may benefit from 15 different FDA-approved targeted treatment options,” as well as clinical trial eligibility, “with one test report, avoiding duplicative biopsies,” the agency said in a statement.
On the same day as the approval, the Centers for Medicare & Medicaid Services proposed nationwide coverage for Medicare beneficiaries with recurrent or metastatic disease. CMS is accepting public comments on the proposal for 30 days. The cost of the test is $5,800.
F1CDx went through the FDA and CMS Parallel Review Program, in which the agencies review medical devices concurrently to help reduce the time between approval and Medicare coverage.
F1CDx reads the order of nucleotides on DNA isolated from biopsy specimens to detect a range of genetic anomalies, including base substitutions, insertion and deletion alterations, copy number alterations, and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden. Clinical performance was established by comparing the F1CDx to previously approved tests.
The Food and Drug Administration approved a new genetic sequencing test that detects mutations across 324 genes in tumor biopsy specimens with an accuracy of 94.6%.
The FoundationOne CDx (F1CDx) test from Foundation Medicine “can identify which patients with any of five tumor types” – non–small-cell lung cancer, melanoma, breast cancer, colorectal cancer, or ovarian cancer – “may benefit from 15 different FDA-approved targeted treatment options,” as well as clinical trial eligibility, “with one test report, avoiding duplicative biopsies,” the agency said in a statement.
On the same day as the approval, the Centers for Medicare & Medicaid Services proposed nationwide coverage for Medicare beneficiaries with recurrent or metastatic disease. CMS is accepting public comments on the proposal for 30 days. The cost of the test is $5,800.
F1CDx went through the FDA and CMS Parallel Review Program, in which the agencies review medical devices concurrently to help reduce the time between approval and Medicare coverage.
F1CDx reads the order of nucleotides on DNA isolated from biopsy specimens to detect a range of genetic anomalies, including base substitutions, insertion and deletion alterations, copy number alterations, and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden. Clinical performance was established by comparing the F1CDx to previously approved tests.
The Food and Drug Administration approved a new genetic sequencing test that detects mutations across 324 genes in tumor biopsy specimens with an accuracy of 94.6%.
The FoundationOne CDx (F1CDx) test from Foundation Medicine “can identify which patients with any of five tumor types” – non–small-cell lung cancer, melanoma, breast cancer, colorectal cancer, or ovarian cancer – “may benefit from 15 different FDA-approved targeted treatment options,” as well as clinical trial eligibility, “with one test report, avoiding duplicative biopsies,” the agency said in a statement.
On the same day as the approval, the Centers for Medicare & Medicaid Services proposed nationwide coverage for Medicare beneficiaries with recurrent or metastatic disease. CMS is accepting public comments on the proposal for 30 days. The cost of the test is $5,800.
F1CDx went through the FDA and CMS Parallel Review Program, in which the agencies review medical devices concurrently to help reduce the time between approval and Medicare coverage.
F1CDx reads the order of nucleotides on DNA isolated from biopsy specimens to detect a range of genetic anomalies, including base substitutions, insertion and deletion alterations, copy number alterations, and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden. Clinical performance was established by comparing the F1CDx to previously approved tests.
Delayed HIV diagnoses still substantial for some at-risk groups
HIV diagnoses are coming sooner after infection, increasing physicians’ ability to treat and prevent the spread of HIV, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report.
As HIV testing has increased, the percentage of people aware of their HIV infection has also steadily grown. As of 2014, 85% of people living with HIV in the United States were aware of their infection. This knowledge allows individuals to seek antiretroviral treatment to suppress the virus, which decreases morbidity and mortality while reducing the risk of sexual transmission to others; knowing one’s HIV status, then, is incredibly important, clinicians say, because people who are unaware that they are HIV positive account for approximately 40% of ongoing transmissions.
While HIV testing has led to a reduction of HIV infection in the total population, several groups that are at a high risk of HIV infection are not getting tested as often as they should. According to the report, 29% of men who have sex with men, 42% of intravenous drugs users, and 59% of heterosexuals did not report having been tested within the past 12 months. Of the risk groups mentioned, at least two-thirds of people in each group had seen a health care provider in the last year. Heterosexual men are at particular risk of going undiagnosed because they are less likely to see a health care provider. This has led to half of heterosexual men who have HIV going undiagnosed for 5 years or more, the report notes.
Health care providers can improve testing by discussing HIV with patients and explaining that HIV testing is a routine part of any patient’s health care. Physicians should routinely test all patients aged 13-64 years, the CDC says. Testing should be emphasized in patients in high-risk groups; these patients should be tested at least once a year. Sexually active gay and bisexual men should ideally be tested every 3-6 months. Pregnant women, or those looking to become pregnant, should be tested to as soon as possible. If a pregnant woman is in a high-risk population, she should be tested again in the third trimester.
If a patient tests positive for HIV, the CDC report says it is important for clinicians connect them with treatment options and discuss prevention of transmission. The earlier a person begins HIV treatment, the greater the benefits will be. As part of the treatment, clinicians should encourage patients to stay on antiretroviral care to reduce the viral load in the body to either very low (less than 200 copies/mL) or undetectable levels.
“HIV is being diagnosed more quickly, the number of people who have the virus under control is up, and annual infections are down. So while we celebrate our progress, we pledge to work together to end this epidemic forever,” said CDC Director Brenda Fitzgerald, MD, in a statement.
HIV diagnoses are coming sooner after infection, increasing physicians’ ability to treat and prevent the spread of HIV, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report.
As HIV testing has increased, the percentage of people aware of their HIV infection has also steadily grown. As of 2014, 85% of people living with HIV in the United States were aware of their infection. This knowledge allows individuals to seek antiretroviral treatment to suppress the virus, which decreases morbidity and mortality while reducing the risk of sexual transmission to others; knowing one’s HIV status, then, is incredibly important, clinicians say, because people who are unaware that they are HIV positive account for approximately 40% of ongoing transmissions.
While HIV testing has led to a reduction of HIV infection in the total population, several groups that are at a high risk of HIV infection are not getting tested as often as they should. According to the report, 29% of men who have sex with men, 42% of intravenous drugs users, and 59% of heterosexuals did not report having been tested within the past 12 months. Of the risk groups mentioned, at least two-thirds of people in each group had seen a health care provider in the last year. Heterosexual men are at particular risk of going undiagnosed because they are less likely to see a health care provider. This has led to half of heterosexual men who have HIV going undiagnosed for 5 years or more, the report notes.
Health care providers can improve testing by discussing HIV with patients and explaining that HIV testing is a routine part of any patient’s health care. Physicians should routinely test all patients aged 13-64 years, the CDC says. Testing should be emphasized in patients in high-risk groups; these patients should be tested at least once a year. Sexually active gay and bisexual men should ideally be tested every 3-6 months. Pregnant women, or those looking to become pregnant, should be tested to as soon as possible. If a pregnant woman is in a high-risk population, she should be tested again in the third trimester.
If a patient tests positive for HIV, the CDC report says it is important for clinicians connect them with treatment options and discuss prevention of transmission. The earlier a person begins HIV treatment, the greater the benefits will be. As part of the treatment, clinicians should encourage patients to stay on antiretroviral care to reduce the viral load in the body to either very low (less than 200 copies/mL) or undetectable levels.
“HIV is being diagnosed more quickly, the number of people who have the virus under control is up, and annual infections are down. So while we celebrate our progress, we pledge to work together to end this epidemic forever,” said CDC Director Brenda Fitzgerald, MD, in a statement.
HIV diagnoses are coming sooner after infection, increasing physicians’ ability to treat and prevent the spread of HIV, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report.
As HIV testing has increased, the percentage of people aware of their HIV infection has also steadily grown. As of 2014, 85% of people living with HIV in the United States were aware of their infection. This knowledge allows individuals to seek antiretroviral treatment to suppress the virus, which decreases morbidity and mortality while reducing the risk of sexual transmission to others; knowing one’s HIV status, then, is incredibly important, clinicians say, because people who are unaware that they are HIV positive account for approximately 40% of ongoing transmissions.
While HIV testing has led to a reduction of HIV infection in the total population, several groups that are at a high risk of HIV infection are not getting tested as often as they should. According to the report, 29% of men who have sex with men, 42% of intravenous drugs users, and 59% of heterosexuals did not report having been tested within the past 12 months. Of the risk groups mentioned, at least two-thirds of people in each group had seen a health care provider in the last year. Heterosexual men are at particular risk of going undiagnosed because they are less likely to see a health care provider. This has led to half of heterosexual men who have HIV going undiagnosed for 5 years or more, the report notes.
Health care providers can improve testing by discussing HIV with patients and explaining that HIV testing is a routine part of any patient’s health care. Physicians should routinely test all patients aged 13-64 years, the CDC says. Testing should be emphasized in patients in high-risk groups; these patients should be tested at least once a year. Sexually active gay and bisexual men should ideally be tested every 3-6 months. Pregnant women, or those looking to become pregnant, should be tested to as soon as possible. If a pregnant woman is in a high-risk population, she should be tested again in the third trimester.
If a patient tests positive for HIV, the CDC report says it is important for clinicians connect them with treatment options and discuss prevention of transmission. The earlier a person begins HIV treatment, the greater the benefits will be. As part of the treatment, clinicians should encourage patients to stay on antiretroviral care to reduce the viral load in the body to either very low (less than 200 copies/mL) or undetectable levels.
“HIV is being diagnosed more quickly, the number of people who have the virus under control is up, and annual infections are down. So while we celebrate our progress, we pledge to work together to end this epidemic forever,” said CDC Director Brenda Fitzgerald, MD, in a statement.
FROM CDC VITAL SIGNS REPORT
Key clinical point:
Major finding: Approximately 15% of those living with HIV in 2015 were unaware of their infection and had a median diagnosis delay of 3 years.
Data source: Data of 39,720 individuals reported to the CDC’s National HIV Surveillance System from 50 states and the District of Columbia in 2015.
Disclosures: No conflicts of interest were reported.
FDA approves epinephrine autoinjector for infants, small children
The Food and Drug Administration approved an epinephrine autoinjector constructed specifically to treat life-threatening allergic reactions in infants and small children weighing 16.5-33 pounds.
The Auvi-Q 0.1 mg autoinjector by kaléo was approved after a priority review by the FDA, with features such as “a voice prompt system that guides a user with step-by-step instructions through the delivery process,” according to a written statement from the company. This auto-injector has a shorter needle length and lower dose of epinephrine than other FDA-approved 0.15-mg and 0.3-mg epinephrine autoinjectors.
In a previous study of 51 infants with a mean weight of 24 pounds who were treated with a 0.15-mg epinephrine auto-injector with a standard 12.7-mm needle length, 43% were at risk of having the needle strike the bone. Unintentional injection of epinephrine into the intraosseous space can cause systemic absorption of the epinephrine and possible cardiac complications (Ann Allergy Asthma Immunol. 2017 Jun;118[6]:719-25.e1).
This new autoinjector with a shorter needle length was designed to obviate this problem, according to kaléo’s statement.
The Auvi-Q 0.1 mg autoinjector should be available to patients in the first half of 2018, the company said.
The Food and Drug Administration approved an epinephrine autoinjector constructed specifically to treat life-threatening allergic reactions in infants and small children weighing 16.5-33 pounds.
The Auvi-Q 0.1 mg autoinjector by kaléo was approved after a priority review by the FDA, with features such as “a voice prompt system that guides a user with step-by-step instructions through the delivery process,” according to a written statement from the company. This auto-injector has a shorter needle length and lower dose of epinephrine than other FDA-approved 0.15-mg and 0.3-mg epinephrine autoinjectors.
In a previous study of 51 infants with a mean weight of 24 pounds who were treated with a 0.15-mg epinephrine auto-injector with a standard 12.7-mm needle length, 43% were at risk of having the needle strike the bone. Unintentional injection of epinephrine into the intraosseous space can cause systemic absorption of the epinephrine and possible cardiac complications (Ann Allergy Asthma Immunol. 2017 Jun;118[6]:719-25.e1).
This new autoinjector with a shorter needle length was designed to obviate this problem, according to kaléo’s statement.
The Auvi-Q 0.1 mg autoinjector should be available to patients in the first half of 2018, the company said.
The Food and Drug Administration approved an epinephrine autoinjector constructed specifically to treat life-threatening allergic reactions in infants and small children weighing 16.5-33 pounds.
The Auvi-Q 0.1 mg autoinjector by kaléo was approved after a priority review by the FDA, with features such as “a voice prompt system that guides a user with step-by-step instructions through the delivery process,” according to a written statement from the company. This auto-injector has a shorter needle length and lower dose of epinephrine than other FDA-approved 0.15-mg and 0.3-mg epinephrine autoinjectors.
In a previous study of 51 infants with a mean weight of 24 pounds who were treated with a 0.15-mg epinephrine auto-injector with a standard 12.7-mm needle length, 43% were at risk of having the needle strike the bone. Unintentional injection of epinephrine into the intraosseous space can cause systemic absorption of the epinephrine and possible cardiac complications (Ann Allergy Asthma Immunol. 2017 Jun;118[6]:719-25.e1).
This new autoinjector with a shorter needle length was designed to obviate this problem, according to kaléo’s statement.
The Auvi-Q 0.1 mg autoinjector should be available to patients in the first half of 2018, the company said.
FDA approves first-in-class drug for hemophilia A with Factor VIII
The Food and Drug Administration has approved emicizumab-kxwh (Hemlibra) for the prevention or reduction of bleeding episodes for adult and pediatric patients with hemophilia A with Factor VIII inhibitors.
The drug received the FDA’s Priority Review, Breakthrough Therapy, and Orphan Drug designations.
It was shown to be safe and effective in two clinical trials, one of boys and men aged 12 years and older and the other of boys younger than 12 years. In the first trial, patients taking emicizumab-kxwh had an 87% reduction in the rate of treated bleeding episodes per year, compared with patients not receiving prophylactic treatment (2.9 vs. 23.3; P less than .0001).
In the second trial, 87% of the children receiving emicizumab-kxwh did not experience a bleeding episode that required treatment.
The most common adverse events were injection site reactions, headache, and arthralgia. The drug labeling includes a boxed warning about the possibility of thrombotic microangiopathy and thromboembolism in patients given an activated prothrombin complex concentrate rescue treatment for 24 hours or more while taking emicizumab-kxwh.
The Food and Drug Administration has approved emicizumab-kxwh (Hemlibra) for the prevention or reduction of bleeding episodes for adult and pediatric patients with hemophilia A with Factor VIII inhibitors.
The drug received the FDA’s Priority Review, Breakthrough Therapy, and Orphan Drug designations.
It was shown to be safe and effective in two clinical trials, one of boys and men aged 12 years and older and the other of boys younger than 12 years. In the first trial, patients taking emicizumab-kxwh had an 87% reduction in the rate of treated bleeding episodes per year, compared with patients not receiving prophylactic treatment (2.9 vs. 23.3; P less than .0001).
In the second trial, 87% of the children receiving emicizumab-kxwh did not experience a bleeding episode that required treatment.
The most common adverse events were injection site reactions, headache, and arthralgia. The drug labeling includes a boxed warning about the possibility of thrombotic microangiopathy and thromboembolism in patients given an activated prothrombin complex concentrate rescue treatment for 24 hours or more while taking emicizumab-kxwh.
The Food and Drug Administration has approved emicizumab-kxwh (Hemlibra) for the prevention or reduction of bleeding episodes for adult and pediatric patients with hemophilia A with Factor VIII inhibitors.
The drug received the FDA’s Priority Review, Breakthrough Therapy, and Orphan Drug designations.
It was shown to be safe and effective in two clinical trials, one of boys and men aged 12 years and older and the other of boys younger than 12 years. In the first trial, patients taking emicizumab-kxwh had an 87% reduction in the rate of treated bleeding episodes per year, compared with patients not receiving prophylactic treatment (2.9 vs. 23.3; P less than .0001).
In the second trial, 87% of the children receiving emicizumab-kxwh did not experience a bleeding episode that required treatment.
The most common adverse events were injection site reactions, headache, and arthralgia. The drug labeling includes a boxed warning about the possibility of thrombotic microangiopathy and thromboembolism in patients given an activated prothrombin complex concentrate rescue treatment for 24 hours or more while taking emicizumab-kxwh.
FDA: Febuxostat may have increased heart-related death risk
The urate-lowering therapy febuxostat may have a higher risk of heart-related death than does another urate-lowering drug, allopurinol, according to a Safety Alert from the Food and Drug Administration.
The safety trial was commissioned after febuxostat was approved by the FDA in 2009. Clinical trials conducted pre-approval showed an increased risk of heart-related problems, compared with allopurinol, and the drug label already carries a warning about cardiovascular events.
“Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information,” the agency said in the Safety Alert.
lfranki@frontlinemedcom.com
The urate-lowering therapy febuxostat may have a higher risk of heart-related death than does another urate-lowering drug, allopurinol, according to a Safety Alert from the Food and Drug Administration.
The safety trial was commissioned after febuxostat was approved by the FDA in 2009. Clinical trials conducted pre-approval showed an increased risk of heart-related problems, compared with allopurinol, and the drug label already carries a warning about cardiovascular events.
“Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information,” the agency said in the Safety Alert.
lfranki@frontlinemedcom.com
The urate-lowering therapy febuxostat may have a higher risk of heart-related death than does another urate-lowering drug, allopurinol, according to a Safety Alert from the Food and Drug Administration.
The safety trial was commissioned after febuxostat was approved by the FDA in 2009. Clinical trials conducted pre-approval showed an increased risk of heart-related problems, compared with allopurinol, and the drug label already carries a warning about cardiovascular events.
“Once the final results from the manufacturer are received, the FDA will conduct a comprehensive review and will update the public with any new information,” the agency said in the Safety Alert.
lfranki@frontlinemedcom.com
FDA approves obinutuzumab for follicular lymphoma
The Food and Drug Administration has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The most common adverse events associated with obinutuzumab were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. The most common significant adverse events are low white blood cell count, low white blood cell count with fever, and low platelet count.
Obinutuzumab is marketed as Gazyva by Genentech.
“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sarah Horning, MD, chief medical officer and head of global product development at Genentech, in the company press release.
The Food and Drug Administration has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The most common adverse events associated with obinutuzumab were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. The most common significant adverse events are low white blood cell count, low white blood cell count with fever, and low platelet count.
Obinutuzumab is marketed as Gazyva by Genentech.
“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sarah Horning, MD, chief medical officer and head of global product development at Genentech, in the company press release.
The Food and Drug Administration has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The most common adverse events associated with obinutuzumab were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. The most common significant adverse events are low white blood cell count, low white blood cell count with fever, and low platelet count.
Obinutuzumab is marketed as Gazyva by Genentech.
“Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said Sarah Horning, MD, chief medical officer and head of global product development at Genentech, in the company press release.
FDA approves sunitinib malate as adjuvant treatment for RCC
The Food and Drug Administration has approved sunitinib malate for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
“This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” 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 a written statement.
Approval for adjuvant treatment of RCC was based on median disease-free survival of 6.8 years for patients receiving sunitinib malate, compared with 5.6 years for patients receiving placebo in S-TRAC, a phase III trial of 615 patients with high risk of recurrent RCC following nephrectomy. In the trial, presented at the European Society for Medical Oncology Congress in 2016 and published in the New England Journal of Medicine, patients were randomized 1:1 to receive either 50 mg sunitinib malate once daily, 4 weeks on treatment followed by 2 weeks off, or placebo. Overall survival data were not mature at the time of data analysis.
The most common adverse reactions to sunitinib in the trial were fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and thrombocytopenia.
Severe side effects included hepatotoxicity, low left ventricular ejection fraction, myocardial ischemia/infarction, prolonged QT intervals/torsade de pointes, hypertension, hemorrhagic events, tumor lysis syndrome, thrombotic microangiopathy (including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome), proteinuria, thyroid dysfunction, hypoglycemia, osteonecrosis, and wound-healing complications. A boxed warning alerts health care professionals and patients about the risk of hepatoxicity, which may result in liver failure or death.
Sunitinib malate is marketed as Sutent by Pfizer. The recommended dose for the adjuvant treatment of RCC is 50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off for nine 6-week cycles.
Full prescribing information is available here.
The Food and Drug Administration has approved sunitinib malate for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
“This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” 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 a written statement.
Approval for adjuvant treatment of RCC was based on median disease-free survival of 6.8 years for patients receiving sunitinib malate, compared with 5.6 years for patients receiving placebo in S-TRAC, a phase III trial of 615 patients with high risk of recurrent RCC following nephrectomy. In the trial, presented at the European Society for Medical Oncology Congress in 2016 and published in the New England Journal of Medicine, patients were randomized 1:1 to receive either 50 mg sunitinib malate once daily, 4 weeks on treatment followed by 2 weeks off, or placebo. Overall survival data were not mature at the time of data analysis.
The most common adverse reactions to sunitinib in the trial were fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and thrombocytopenia.
Severe side effects included hepatotoxicity, low left ventricular ejection fraction, myocardial ischemia/infarction, prolonged QT intervals/torsade de pointes, hypertension, hemorrhagic events, tumor lysis syndrome, thrombotic microangiopathy (including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome), proteinuria, thyroid dysfunction, hypoglycemia, osteonecrosis, and wound-healing complications. A boxed warning alerts health care professionals and patients about the risk of hepatoxicity, which may result in liver failure or death.
Sunitinib malate is marketed as Sutent by Pfizer. The recommended dose for the adjuvant treatment of RCC is 50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off for nine 6-week cycles.
Full prescribing information is available here.
The Food and Drug Administration has approved sunitinib malate for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
“This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” 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 a written statement.
Approval for adjuvant treatment of RCC was based on median disease-free survival of 6.8 years for patients receiving sunitinib malate, compared with 5.6 years for patients receiving placebo in S-TRAC, a phase III trial of 615 patients with high risk of recurrent RCC following nephrectomy. In the trial, presented at the European Society for Medical Oncology Congress in 2016 and published in the New England Journal of Medicine, patients were randomized 1:1 to receive either 50 mg sunitinib malate once daily, 4 weeks on treatment followed by 2 weeks off, or placebo. Overall survival data were not mature at the time of data analysis.
The most common adverse reactions to sunitinib in the trial were fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and thrombocytopenia.
Severe side effects included hepatotoxicity, low left ventricular ejection fraction, myocardial ischemia/infarction, prolonged QT intervals/torsade de pointes, hypertension, hemorrhagic events, tumor lysis syndrome, thrombotic microangiopathy (including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome), proteinuria, thyroid dysfunction, hypoglycemia, osteonecrosis, and wound-healing complications. A boxed warning alerts health care professionals and patients about the risk of hepatoxicity, which may result in liver failure or death.
Sunitinib malate is marketed as Sutent by Pfizer. The recommended dose for the adjuvant treatment of RCC is 50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off for nine 6-week cycles.
Full prescribing information is available here.
FDA authorizes next-generation sequencing test for tumor profiling
The Food and Drug Administration has authorized a new tumor profiling test that can identify a larger number of genetic mutations than available in any other test previously reviewed, the agency has announced.
The tumor profiling test, developed at Memorial Sloan Kettering Cancer Center and known as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), is a custom targeted sequencing platform that uses exon capture and sequencing, so-called next-generation sequencing, to identify point mutations, small insertions and deletions, and microsatellite instability in tumor specimens. The assay involves hybridization capture and deep sequencing of all protein coding exons of 468 cancer-associated genes, as well as molecular changes in a tumor’s genomic makeup, according to the FDA announcement.
Unlike cancer diagnostic tests designed to determine the presence of one cancer biomarker for use with a single drug, the IMPACT test compares tumor tissue to a “normal” tissue or cell sample from the same patient to find genetic alterations that could potentially guide treatment options. However, the FDA said, the results of IMPACT are “not conclusive” for choosing a corresponding treatment.
Next-generation sequencing technologies can examine “hundreds, if not millions, of DNA variants at a time,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the announcement. “We are only at the beginning of realizing the true potential for these devices to assist patients and their health care providers in learning about the genetic underpinnings of their disease.”
Evaluations of IMPACT suggest the assay is “highly accurate” with a greater than 99% capability of detecting a mutation at a frequency of approximately 5%, according to the FDA.
In addition, detection of molecular changes, including microsatellite instability, were concordant more than 92% of the time when compared with traditional detection methods, the agency said.
Along with the marketing authorization for IMPACT, which was granted to Memorial Sloan Kettering Cancer Center, the agency announced that the New York State Department of Health has been accredited as an FDA third-party reviewer of in vitro diagnostics similar to IMPACT.
That action “paves the way” for efficient review and availability of other next-generation sequencing–based cancer profiling tools.
Allowing third parties to review next-generation sequencing–based tumor profiling tests will “reduce the burden on test developers and streamline the regulatory assessment of these types of innovative products,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.
The Food and Drug Administration has authorized a new tumor profiling test that can identify a larger number of genetic mutations than available in any other test previously reviewed, the agency has announced.
The tumor profiling test, developed at Memorial Sloan Kettering Cancer Center and known as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), is a custom targeted sequencing platform that uses exon capture and sequencing, so-called next-generation sequencing, to identify point mutations, small insertions and deletions, and microsatellite instability in tumor specimens. The assay involves hybridization capture and deep sequencing of all protein coding exons of 468 cancer-associated genes, as well as molecular changes in a tumor’s genomic makeup, according to the FDA announcement.
Unlike cancer diagnostic tests designed to determine the presence of one cancer biomarker for use with a single drug, the IMPACT test compares tumor tissue to a “normal” tissue or cell sample from the same patient to find genetic alterations that could potentially guide treatment options. However, the FDA said, the results of IMPACT are “not conclusive” for choosing a corresponding treatment.
Next-generation sequencing technologies can examine “hundreds, if not millions, of DNA variants at a time,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the announcement. “We are only at the beginning of realizing the true potential for these devices to assist patients and their health care providers in learning about the genetic underpinnings of their disease.”
Evaluations of IMPACT suggest the assay is “highly accurate” with a greater than 99% capability of detecting a mutation at a frequency of approximately 5%, according to the FDA.
In addition, detection of molecular changes, including microsatellite instability, were concordant more than 92% of the time when compared with traditional detection methods, the agency said.
Along with the marketing authorization for IMPACT, which was granted to Memorial Sloan Kettering Cancer Center, the agency announced that the New York State Department of Health has been accredited as an FDA third-party reviewer of in vitro diagnostics similar to IMPACT.
That action “paves the way” for efficient review and availability of other next-generation sequencing–based cancer profiling tools.
Allowing third parties to review next-generation sequencing–based tumor profiling tests will “reduce the burden on test developers and streamline the regulatory assessment of these types of innovative products,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.
The Food and Drug Administration has authorized a new tumor profiling test that can identify a larger number of genetic mutations than available in any other test previously reviewed, the agency has announced.
The tumor profiling test, developed at Memorial Sloan Kettering Cancer Center and known as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), is a custom targeted sequencing platform that uses exon capture and sequencing, so-called next-generation sequencing, to identify point mutations, small insertions and deletions, and microsatellite instability in tumor specimens. The assay involves hybridization capture and deep sequencing of all protein coding exons of 468 cancer-associated genes, as well as molecular changes in a tumor’s genomic makeup, according to the FDA announcement.
Unlike cancer diagnostic tests designed to determine the presence of one cancer biomarker for use with a single drug, the IMPACT test compares tumor tissue to a “normal” tissue or cell sample from the same patient to find genetic alterations that could potentially guide treatment options. However, the FDA said, the results of IMPACT are “not conclusive” for choosing a corresponding treatment.
Next-generation sequencing technologies can examine “hundreds, if not millions, of DNA variants at a time,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the announcement. “We are only at the beginning of realizing the true potential for these devices to assist patients and their health care providers in learning about the genetic underpinnings of their disease.”
Evaluations of IMPACT suggest the assay is “highly accurate” with a greater than 99% capability of detecting a mutation at a frequency of approximately 5%, according to the FDA.
In addition, detection of molecular changes, including microsatellite instability, were concordant more than 92% of the time when compared with traditional detection methods, the agency said.
Along with the marketing authorization for IMPACT, which was granted to Memorial Sloan Kettering Cancer Center, the agency announced that the New York State Department of Health has been accredited as an FDA third-party reviewer of in vitro diagnostics similar to IMPACT.
That action “paves the way” for efficient review and availability of other next-generation sequencing–based cancer profiling tools.
Allowing third parties to review next-generation sequencing–based tumor profiling tests will “reduce the burden on test developers and streamline the regulatory assessment of these types of innovative products,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.