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Dr. William J. Gradishar shares breast cancer take-aways from ASCO 2018
CHICAGO – William J. Gradishar, MD, discussed the clinical impact of breast cancer research presented at the annual meeting of the American Society of Clinical Oncology.
In a video interview, Dr. Gradishar, the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago, said TAILORx was a “big win” in that it has no doubt diminished the number of women with early-stage breast cancer who will require chemotherapy. However, although the trial has provided some clarity, it also has left some questions open, particularly for patients under 50 years of age, he said.
Dr. Gradishar also discussed the results of combination trials of targeted therapy with either endocrine therapy or chemotherapy. In discussing SANDPIPER, which evaluated whether a phosphoinositide 3-kinase inhibitor could enhance the effect of anti-hormonal therapy, he said that although it was a positive trial, “from a clinician’s standpoint, it’s probably not sufficient in my mind to get really excited about.”
CHICAGO – William J. Gradishar, MD, discussed the clinical impact of breast cancer research presented at the annual meeting of the American Society of Clinical Oncology.
In a video interview, Dr. Gradishar, the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago, said TAILORx was a “big win” in that it has no doubt diminished the number of women with early-stage breast cancer who will require chemotherapy. However, although the trial has provided some clarity, it also has left some questions open, particularly for patients under 50 years of age, he said.
Dr. Gradishar also discussed the results of combination trials of targeted therapy with either endocrine therapy or chemotherapy. In discussing SANDPIPER, which evaluated whether a phosphoinositide 3-kinase inhibitor could enhance the effect of anti-hormonal therapy, he said that although it was a positive trial, “from a clinician’s standpoint, it’s probably not sufficient in my mind to get really excited about.”
CHICAGO – William J. Gradishar, MD, discussed the clinical impact of breast cancer research presented at the annual meeting of the American Society of Clinical Oncology.
In a video interview, Dr. Gradishar, the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago, said TAILORx was a “big win” in that it has no doubt diminished the number of women with early-stage breast cancer who will require chemotherapy. However, although the trial has provided some clarity, it also has left some questions open, particularly for patients under 50 years of age, he said.
Dr. Gradishar also discussed the results of combination trials of targeted therapy with either endocrine therapy or chemotherapy. In discussing SANDPIPER, which evaluated whether a phosphoinositide 3-kinase inhibitor could enhance the effect of anti-hormonal therapy, he said that although it was a positive trial, “from a clinician’s standpoint, it’s probably not sufficient in my mind to get really excited about.”
REPORTING FROM ASCO 2018
New cases of Merkel cell carcinoma increased 95% between 2000 and 2013
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
The number of new cases per year of Merkel cell carcinoma (MCC) increased by 95% during 2000-2013, according to a review of Surveillance, Epidemiology, and End Results (SEER) data.
There were 652 cases of MCC in the SEER-18 registry in 2013, up from the 334 cases captured by the database in 2000.
This increase exceeded the 56.5% increase seen with melanoma over the same time period, the investigators wrote in the Journal of the American Academy of Dermatology.
The total number of incident MCC cases in the United States in 2013 was calculated as 2,488 cases/year by using SEER-derived incidence rates combined with U.S. Census population data. The MCC incidence rate rose precipitously with age, increasing 10-fold between ages 40-44 years (0.1 cases/100,000 person-years) and ages 60-64 years (0.9 cases/100,000 person-years).
Given the aging of the population and an assumption that the incidence rates within any given age group will remain stable, the annual incidence of Merkel cell carcinoma in the United States will increase to 3,284 cases/year in 2025, Kelly G. Paulson, MD, PhD, of the Fred Hutchinson Cancer Research Center, Seattle, and her colleagues projected.
“The incidence of MCC is increasing and will likely continue to rise as the Baby Boomer population enters the higher-risk age groups for MCC,” Dr. Paulson and colleagues said. ”Because of its high propensity for spread, the need for adjuvant radiation in many cases, and the clear role for early immunotherapy in the metastatic setting, both early detection and optimal management will be critical for improved outcomes,” they concluded.
SOURCE: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3):457-463.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
The number of new cases per year of Merkel cell carcinoma (MCC) increased by 95% during 2000-2013, according to a review of Surveillance, Epidemiology, and End Results (SEER) data.
There were 652 cases of MCC in the SEER-18 registry in 2013, up from the 334 cases captured by the database in 2000.
This increase exceeded the 56.5% increase seen with melanoma over the same time period, the investigators wrote in the Journal of the American Academy of Dermatology.
The total number of incident MCC cases in the United States in 2013 was calculated as 2,488 cases/year by using SEER-derived incidence rates combined with U.S. Census population data. The MCC incidence rate rose precipitously with age, increasing 10-fold between ages 40-44 years (0.1 cases/100,000 person-years) and ages 60-64 years (0.9 cases/100,000 person-years).
Given the aging of the population and an assumption that the incidence rates within any given age group will remain stable, the annual incidence of Merkel cell carcinoma in the United States will increase to 3,284 cases/year in 2025, Kelly G. Paulson, MD, PhD, of the Fred Hutchinson Cancer Research Center, Seattle, and her colleagues projected.
“The incidence of MCC is increasing and will likely continue to rise as the Baby Boomer population enters the higher-risk age groups for MCC,” Dr. Paulson and colleagues said. ”Because of its high propensity for spread, the need for adjuvant radiation in many cases, and the clear role for early immunotherapy in the metastatic setting, both early detection and optimal management will be critical for improved outcomes,” they concluded.
SOURCE: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3):457-463.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
The number of new cases per year of Merkel cell carcinoma (MCC) increased by 95% during 2000-2013, according to a review of Surveillance, Epidemiology, and End Results (SEER) data.
There were 652 cases of MCC in the SEER-18 registry in 2013, up from the 334 cases captured by the database in 2000.
This increase exceeded the 56.5% increase seen with melanoma over the same time period, the investigators wrote in the Journal of the American Academy of Dermatology.
The total number of incident MCC cases in the United States in 2013 was calculated as 2,488 cases/year by using SEER-derived incidence rates combined with U.S. Census population data. The MCC incidence rate rose precipitously with age, increasing 10-fold between ages 40-44 years (0.1 cases/100,000 person-years) and ages 60-64 years (0.9 cases/100,000 person-years).
Given the aging of the population and an assumption that the incidence rates within any given age group will remain stable, the annual incidence of Merkel cell carcinoma in the United States will increase to 3,284 cases/year in 2025, Kelly G. Paulson, MD, PhD, of the Fred Hutchinson Cancer Research Center, Seattle, and her colleagues projected.
“The incidence of MCC is increasing and will likely continue to rise as the Baby Boomer population enters the higher-risk age groups for MCC,” Dr. Paulson and colleagues said. ”Because of its high propensity for spread, the need for adjuvant radiation in many cases, and the clear role for early immunotherapy in the metastatic setting, both early detection and optimal management will be critical for improved outcomes,” they concluded.
SOURCE: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3):457-463.
Key clinical point: The incidence of Merkel cell carcinoma (MCC) is expected to continue at a brisk increase.
Major finding: During 2000-2013, the rate of new U.S. MCC cases increased by 95% to 2,488 diagnoses/year.
Study details: Incidence and future projections were calculated by combining registry data from the SEER-18 Database and U.S. Census data.
Disclosures: The study was funded by grants from the National Institutes of Health, the Prostate Cancer Foundation, the University of Washington MCC Patient Gift Fund, and the Bloom endowment at University of Washington in Seattle. One coauthor disclosed support from EMD Serono, Pfizer, and Bristol-Meyers Squibb. All other authors had no conflicts of interest.
Source: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3): 457-63.
Company discontinues phase 3 ADAPT for mRCC
A second interim analysis of
In ADAPT, 462 patients with previously untreated advanced or metastatic renal cell carcinoma (mRCC) were randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib versus sunitinib monotherapy, after undergoing cytoreductive nephrectomy.
In February 2017, the trial’s Independent Data Monitoring Committee had reviewed the data and concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended halting the trial. However, the principal investigators and the company, Argos Therapeutics, considered the data too immature to observe the delayed effects associated with immunotherapy and decided to continue the trial. They submitted a protocol amendment to the Food and Drug Administration adding additional co-primary endpoints, and in April of last year, met with the Food and Drug Administration, which accepted the amendment and agreed to continuation of the trial, according to a company press release issued in November.
In the latest interim analysis, which was conducted following an additional 51 deaths, median overall survival for the intent-to-treat patient population was 28.2 months for the combination arm (95% confidence interval, 23.4, 35.2) compared with 31.2 months (95% CI, 23.0, 44.5) for the control arm; this was one of four new co-primary endpoints. The hazard ratio was 1.10 (95% CI, 0.85, 1.42).
Other co-primary endpoints that were evaluated, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, did not demonstrate a favorable result, Argos Therapeutics said in a recent press release.
Rocapuldencel-T “consists of autologous dendritic cells programmed with amplified RNA from a patient’s primary tumor” and is “designed to overcome immunosuppression and induce broadly reactive, long-lasting anti-tumor memory T cells” according to the early interim analysis presented at the European Society for Medical Oncology (ESMO) 2017. The drug is also being evaluated in non–small cell lung cancer and bladder cancer.
A second interim analysis of
In ADAPT, 462 patients with previously untreated advanced or metastatic renal cell carcinoma (mRCC) were randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib versus sunitinib monotherapy, after undergoing cytoreductive nephrectomy.
In February 2017, the trial’s Independent Data Monitoring Committee had reviewed the data and concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended halting the trial. However, the principal investigators and the company, Argos Therapeutics, considered the data too immature to observe the delayed effects associated with immunotherapy and decided to continue the trial. They submitted a protocol amendment to the Food and Drug Administration adding additional co-primary endpoints, and in April of last year, met with the Food and Drug Administration, which accepted the amendment and agreed to continuation of the trial, according to a company press release issued in November.
In the latest interim analysis, which was conducted following an additional 51 deaths, median overall survival for the intent-to-treat patient population was 28.2 months for the combination arm (95% confidence interval, 23.4, 35.2) compared with 31.2 months (95% CI, 23.0, 44.5) for the control arm; this was one of four new co-primary endpoints. The hazard ratio was 1.10 (95% CI, 0.85, 1.42).
Other co-primary endpoints that were evaluated, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, did not demonstrate a favorable result, Argos Therapeutics said in a recent press release.
Rocapuldencel-T “consists of autologous dendritic cells programmed with amplified RNA from a patient’s primary tumor” and is “designed to overcome immunosuppression and induce broadly reactive, long-lasting anti-tumor memory T cells” according to the early interim analysis presented at the European Society for Medical Oncology (ESMO) 2017. The drug is also being evaluated in non–small cell lung cancer and bladder cancer.
A second interim analysis of
In ADAPT, 462 patients with previously untreated advanced or metastatic renal cell carcinoma (mRCC) were randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib versus sunitinib monotherapy, after undergoing cytoreductive nephrectomy.
In February 2017, the trial’s Independent Data Monitoring Committee had reviewed the data and concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended halting the trial. However, the principal investigators and the company, Argos Therapeutics, considered the data too immature to observe the delayed effects associated with immunotherapy and decided to continue the trial. They submitted a protocol amendment to the Food and Drug Administration adding additional co-primary endpoints, and in April of last year, met with the Food and Drug Administration, which accepted the amendment and agreed to continuation of the trial, according to a company press release issued in November.
In the latest interim analysis, which was conducted following an additional 51 deaths, median overall survival for the intent-to-treat patient population was 28.2 months for the combination arm (95% confidence interval, 23.4, 35.2) compared with 31.2 months (95% CI, 23.0, 44.5) for the control arm; this was one of four new co-primary endpoints. The hazard ratio was 1.10 (95% CI, 0.85, 1.42).
Other co-primary endpoints that were evaluated, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, did not demonstrate a favorable result, Argos Therapeutics said in a recent press release.
Rocapuldencel-T “consists of autologous dendritic cells programmed with amplified RNA from a patient’s primary tumor” and is “designed to overcome immunosuppression and induce broadly reactive, long-lasting anti-tumor memory T cells” according to the early interim analysis presented at the European Society for Medical Oncology (ESMO) 2017. The drug is also being evaluated in non–small cell lung cancer and bladder cancer.
FDA approves osimertinib for first-line advanced EGFR-mutated NSCLC
(NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.
The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.
Overall survival was not evaluable at the time of the PFS analysis.
The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).
In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.
(NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.
The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.
Overall survival was not evaluable at the time of the PFS analysis.
The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).
In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.
(NSCLC) with epidermal growth factor receptor (EGFR) mutations, as detected by an FDA-approved test.
The drug was approved a year ago for treating those with advanced EGFR-mutated NSCLC and progression following EGFR tyrosine kinase inhibitor therapy.
Overall survival was not evaluable at the time of the PFS analysis.
The most common adverse reactions were diarrhea, rash, dry skin, nail toxicity, stomatitis, and decreased appetite. The most common serious adverse reactions were pneumonia (2.9%), interstitial lung disease/pneumonitis (2.1%), and pulmonary embolism (1.8%).
In FLAURA, patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or gefitinib 250 mg or erlotinib 150 mg orally once daily. One-fifth of those in the control arm went on to receive osimertinib as the second line of therapy.
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor marketed as Tagrisso by AstraZeneca. The recommended dose is 80 mg orally once daily, with or without food, according to the statement.
FDA approves immunotherapy combo for advanced RCC
The Food and Drug Administration has granted approvals to
The approvals were based on statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients receiving the combination of nivolumab and ipilimumab (n = 425), compared with those receiving sunitinib (n = 422) in CheckMate 214, the FDA said in a press statement.
Median OS was not yet reached in the combination arm at follow-up of 32 months, compared with 25.9 months in the sunitinib arm (hazard ratio, 0.63; 95% confidence interval, 0.44-0.89; P less than .0001). The ORR was 41.6% (95% CI, 36.9-46.5) for the combination versus 26.5% (95% CI, 22.4-31) in the sunitinib arm (P less than .0001).
Efficacy of the combination was not established for patients with favorable-risk disease.
The most common adverse reactions were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.
The recommended schedule and dose is 3 mg/kg nivolumab, followed by 1 mg/kg ipilimumab, on the same day every 3 weeks for four doses, then 240 mg nivolumab every 2 weeks or 480 mg every 4 weeks, the FDA said.
Nivolumab is marketed as Opdivo and ipilimumab as Yervoy by Bristol-Myers Squibb.
The Food and Drug Administration has granted approvals to
The approvals were based on statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients receiving the combination of nivolumab and ipilimumab (n = 425), compared with those receiving sunitinib (n = 422) in CheckMate 214, the FDA said in a press statement.
Median OS was not yet reached in the combination arm at follow-up of 32 months, compared with 25.9 months in the sunitinib arm (hazard ratio, 0.63; 95% confidence interval, 0.44-0.89; P less than .0001). The ORR was 41.6% (95% CI, 36.9-46.5) for the combination versus 26.5% (95% CI, 22.4-31) in the sunitinib arm (P less than .0001).
Efficacy of the combination was not established for patients with favorable-risk disease.
The most common adverse reactions were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.
The recommended schedule and dose is 3 mg/kg nivolumab, followed by 1 mg/kg ipilimumab, on the same day every 3 weeks for four doses, then 240 mg nivolumab every 2 weeks or 480 mg every 4 weeks, the FDA said.
Nivolumab is marketed as Opdivo and ipilimumab as Yervoy by Bristol-Myers Squibb.
The Food and Drug Administration has granted approvals to
The approvals were based on statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients receiving the combination of nivolumab and ipilimumab (n = 425), compared with those receiving sunitinib (n = 422) in CheckMate 214, the FDA said in a press statement.
Median OS was not yet reached in the combination arm at follow-up of 32 months, compared with 25.9 months in the sunitinib arm (hazard ratio, 0.63; 95% confidence interval, 0.44-0.89; P less than .0001). The ORR was 41.6% (95% CI, 36.9-46.5) for the combination versus 26.5% (95% CI, 22.4-31) in the sunitinib arm (P less than .0001).
Efficacy of the combination was not established for patients with favorable-risk disease.
The most common adverse reactions were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.
The recommended schedule and dose is 3 mg/kg nivolumab, followed by 1 mg/kg ipilimumab, on the same day every 3 weeks for four doses, then 240 mg nivolumab every 2 weeks or 480 mg every 4 weeks, the FDA said.
Nivolumab is marketed as Opdivo and ipilimumab as Yervoy by Bristol-Myers Squibb.
FDA expands indication for blinatumomab in treating ALL
The Food and Drug Administration has granted accelerated who are in remission but still have minimal residual disease (MRD).
This is the first FDA-approved treatment for those with MRD, the FDA said in a statement.
The current approval was based on a single-arm clinical trial of 86 patients in first or second complete remission who had detectable MRD in at least 1 out of 1,000 cells in their bone marrow. Undetectable MRD was achieved by 70 patients after one cycle of blinatumomab treatment. More than half of the patients remained alive and in remission for at least 22.3 months, the FDA said.
Common side effects include bacterial and pathogen-unspecified infections, pyrexia, headache, infusion-related reactions, neutropenia, anemia, febrile neutropenia, and thrombocytopenia. The drug carries a boxed warning about cytokine release syndrome at the start of the first treatment. The FDA also warns that children weighing less than 22 kg should receive the drug prepared with preservative-free saline because of the risk of serious adverse reactions in pediatric patients from a benzyl alcohol preservative.
Blinatumomab is marketed as Blincyto by Amgen.
The Food and Drug Administration has granted accelerated who are in remission but still have minimal residual disease (MRD).
This is the first FDA-approved treatment for those with MRD, the FDA said in a statement.
The current approval was based on a single-arm clinical trial of 86 patients in first or second complete remission who had detectable MRD in at least 1 out of 1,000 cells in their bone marrow. Undetectable MRD was achieved by 70 patients after one cycle of blinatumomab treatment. More than half of the patients remained alive and in remission for at least 22.3 months, the FDA said.
Common side effects include bacterial and pathogen-unspecified infections, pyrexia, headache, infusion-related reactions, neutropenia, anemia, febrile neutropenia, and thrombocytopenia. The drug carries a boxed warning about cytokine release syndrome at the start of the first treatment. The FDA also warns that children weighing less than 22 kg should receive the drug prepared with preservative-free saline because of the risk of serious adverse reactions in pediatric patients from a benzyl alcohol preservative.
Blinatumomab is marketed as Blincyto by Amgen.
The Food and Drug Administration has granted accelerated who are in remission but still have minimal residual disease (MRD).
This is the first FDA-approved treatment for those with MRD, the FDA said in a statement.
The current approval was based on a single-arm clinical trial of 86 patients in first or second complete remission who had detectable MRD in at least 1 out of 1,000 cells in their bone marrow. Undetectable MRD was achieved by 70 patients after one cycle of blinatumomab treatment. More than half of the patients remained alive and in remission for at least 22.3 months, the FDA said.
Common side effects include bacterial and pathogen-unspecified infections, pyrexia, headache, infusion-related reactions, neutropenia, anemia, febrile neutropenia, and thrombocytopenia. The drug carries a boxed warning about cytokine release syndrome at the start of the first treatment. The FDA also warns that children weighing less than 22 kg should receive the drug prepared with preservative-free saline because of the risk of serious adverse reactions in pediatric patients from a benzyl alcohol preservative.
Blinatumomab is marketed as Blincyto by Amgen.
FDA authorizes first direct-to-consumer BRCA1/2 test
The Food and Drug Administration has authorized the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations.
Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants) does not identify the most common BRCA1/2 mutations but rather the three most common in people of Ashkenazi (Eastern European) Jewish descent, the FDA said in a press statement.
The test, marketed by 23andMe, analyzes DNA from a self-collected saliva sample.
The three mutations identified by the test are present in about 2% of Ashkenazi Jewish women, but rarely in other ethnic populations. Any individual who takes the test may have other mutations in BRCA1 or BRCA2 genes, or other cancer-related gene mutations that are not detected by this test.
“This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the availability of DTC genetic tests. But it has a lot of caveats,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the press statement. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test. The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.”
The authorization was based on data provided by the company to indicate the test correctly identifies the three genetic variants in saliva samples and is reproducible. In addition, the company submitted data to demonstrate that the instructions are comprehensible and easy to follow.
The FDA cautions that consumers and health care professionals “should not use the test results to determine any treatments, including antihormone therapies and prophylactic removal of the breasts or ovaries.” Decisions should be made only after confirmatory testing and genetic counseling, they said.
The Food and Drug Administration has authorized the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations.
Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants) does not identify the most common BRCA1/2 mutations but rather the three most common in people of Ashkenazi (Eastern European) Jewish descent, the FDA said in a press statement.
The test, marketed by 23andMe, analyzes DNA from a self-collected saliva sample.
The three mutations identified by the test are present in about 2% of Ashkenazi Jewish women, but rarely in other ethnic populations. Any individual who takes the test may have other mutations in BRCA1 or BRCA2 genes, or other cancer-related gene mutations that are not detected by this test.
“This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the availability of DTC genetic tests. But it has a lot of caveats,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the press statement. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test. The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.”
The authorization was based on data provided by the company to indicate the test correctly identifies the three genetic variants in saliva samples and is reproducible. In addition, the company submitted data to demonstrate that the instructions are comprehensible and easy to follow.
The FDA cautions that consumers and health care professionals “should not use the test results to determine any treatments, including antihormone therapies and prophylactic removal of the breasts or ovaries.” Decisions should be made only after confirmatory testing and genetic counseling, they said.
The Food and Drug Administration has authorized the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations.
Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants) does not identify the most common BRCA1/2 mutations but rather the three most common in people of Ashkenazi (Eastern European) Jewish descent, the FDA said in a press statement.
The test, marketed by 23andMe, analyzes DNA from a self-collected saliva sample.
The three mutations identified by the test are present in about 2% of Ashkenazi Jewish women, but rarely in other ethnic populations. Any individual who takes the test may have other mutations in BRCA1 or BRCA2 genes, or other cancer-related gene mutations that are not detected by this test.
“This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the availability of DTC genetic tests. But it has a lot of caveats,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the press statement. “While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test. The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.”
The authorization was based on data provided by the company to indicate the test correctly identifies the three genetic variants in saliva samples and is reproducible. In addition, the company submitted data to demonstrate that the instructions are comprehensible and easy to follow.
The FDA cautions that consumers and health care professionals “should not use the test results to determine any treatments, including antihormone therapies and prophylactic removal of the breasts or ovaries.” Decisions should be made only after confirmatory testing and genetic counseling, they said.
FDA approves apalutamide for castration-resistant nonmetastatic prostate cancer
The Food and Drug Administration has approved apalutamide for the treatment of patients with castration-resistant nonmetastatic prostate cancer.
Approval was based on a median metastasis-free survival for patients taking apalutamide of 40.5 months, compared with 16.2 months for patients taking a placebo in a randomized clinical trial of 1,207 patients with nonmetastatic, castration-resistant prostate cancer. All patients also received hormone therapy, either with gonadotropin-releasing hormone analogue therapy or with surgical castration.
Common side effects of apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures, and peripheral edema.
Severe side effects of apalutamide include falls, fractures. and seizures, the FDA said.
Apalutamide is marketed as Erleada by Janssen Biotech.
The Food and Drug Administration has approved apalutamide for the treatment of patients with castration-resistant nonmetastatic prostate cancer.
Approval was based on a median metastasis-free survival for patients taking apalutamide of 40.5 months, compared with 16.2 months for patients taking a placebo in a randomized clinical trial of 1,207 patients with nonmetastatic, castration-resistant prostate cancer. All patients also received hormone therapy, either with gonadotropin-releasing hormone analogue therapy or with surgical castration.
Common side effects of apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures, and peripheral edema.
Severe side effects of apalutamide include falls, fractures. and seizures, the FDA said.
Apalutamide is marketed as Erleada by Janssen Biotech.
The Food and Drug Administration has approved apalutamide for the treatment of patients with castration-resistant nonmetastatic prostate cancer.
Approval was based on a median metastasis-free survival for patients taking apalutamide of 40.5 months, compared with 16.2 months for patients taking a placebo in a randomized clinical trial of 1,207 patients with nonmetastatic, castration-resistant prostate cancer. All patients also received hormone therapy, either with gonadotropin-releasing hormone analogue therapy or with surgical castration.
Common side effects of apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures, and peripheral edema.
Severe side effects of apalutamide include falls, fractures. and seizures, the FDA said.
Apalutamide is marketed as Erleada by Janssen Biotech.
FDA approves abiraterone acetate for metastatic high-risk CSPC
The Food and Drug Administration has approved abiraterone acetate tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).
The FDA first approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer who had received prior chemotherapy. The indication was expanded in 2012 to patients with metastatic castration-resistant prostate cancer, the FDA said in a press statement.
The most common adverse reactions in LATITUDE for patients in the abiraterone acetate arm included hypertension, hot flush, hypokalemia, increased alanine aminotransferase or aspartate aminotransferase, headache, urinary tract infection, upper respiratory tract infection, and cough.
The recommended dose for abiraterone acetate for metastatic CSPC is 1,000 mg orally once daily with prednisone 5 mg orally once daily. Patients receiving the drug should also receive a gonadotropin-releasing hormone analogue concurrently or should have had bilateral orchiectomy, the FDA said.
Abiraterone acetate is marketed as Zytiga by Janssen Biotech.
The Food and Drug Administration has approved abiraterone acetate tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).
The FDA first approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer who had received prior chemotherapy. The indication was expanded in 2012 to patients with metastatic castration-resistant prostate cancer, the FDA said in a press statement.
The most common adverse reactions in LATITUDE for patients in the abiraterone acetate arm included hypertension, hot flush, hypokalemia, increased alanine aminotransferase or aspartate aminotransferase, headache, urinary tract infection, upper respiratory tract infection, and cough.
The recommended dose for abiraterone acetate for metastatic CSPC is 1,000 mg orally once daily with prednisone 5 mg orally once daily. Patients receiving the drug should also receive a gonadotropin-releasing hormone analogue concurrently or should have had bilateral orchiectomy, the FDA said.
Abiraterone acetate is marketed as Zytiga by Janssen Biotech.
The Food and Drug Administration has approved abiraterone acetate tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).
The FDA first approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer who had received prior chemotherapy. The indication was expanded in 2012 to patients with metastatic castration-resistant prostate cancer, the FDA said in a press statement.
The most common adverse reactions in LATITUDE for patients in the abiraterone acetate arm included hypertension, hot flush, hypokalemia, increased alanine aminotransferase or aspartate aminotransferase, headache, urinary tract infection, upper respiratory tract infection, and cough.
The recommended dose for abiraterone acetate for metastatic CSPC is 1,000 mg orally once daily with prednisone 5 mg orally once daily. Patients receiving the drug should also receive a gonadotropin-releasing hormone analogue concurrently or should have had bilateral orchiectomy, the FDA said.
Abiraterone acetate is marketed as Zytiga by Janssen Biotech.
FDA grants priority review to CAR T-cell therapy for DLBCL
The Food and Drug Administration has granted a priority review for the CAR T-cell therapy tisagenlecleucel suspension, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapsed after autologous stem cell transplant.
The current application is based on a 6-month primary analysis from the single-arm, phase 2 JULIET clinical trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma. According to results presented at ASH 2017, among 81 patients followed for at least 3 months before data cutoff, best overall response rate was 53%, and 40% had a complete response. Cytokine release syndrome (all grades) occurred in 58% of infused patients. Other grade 3 or 4 adverse events included neurologic toxicities, cytopenias lasting more than 28 days, infections, and febrile neutropenia.
Tisagenlecleucel suspension is marketed as Kymriah by Novartis.
The Food and Drug Administration has granted a priority review for the CAR T-cell therapy tisagenlecleucel suspension, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapsed after autologous stem cell transplant.
The current application is based on a 6-month primary analysis from the single-arm, phase 2 JULIET clinical trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma. According to results presented at ASH 2017, among 81 patients followed for at least 3 months before data cutoff, best overall response rate was 53%, and 40% had a complete response. Cytokine release syndrome (all grades) occurred in 58% of infused patients. Other grade 3 or 4 adverse events included neurologic toxicities, cytopenias lasting more than 28 days, infections, and febrile neutropenia.
Tisagenlecleucel suspension is marketed as Kymriah by Novartis.
The Food and Drug Administration has granted a priority review for the CAR T-cell therapy tisagenlecleucel suspension, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapsed after autologous stem cell transplant.
The current application is based on a 6-month primary analysis from the single-arm, phase 2 JULIET clinical trial in adult patients with relapsed or refractory diffuse large B-cell lymphoma. According to results presented at ASH 2017, among 81 patients followed for at least 3 months before data cutoff, best overall response rate was 53%, and 40% had a complete response. Cytokine release syndrome (all grades) occurred in 58% of infused patients. Other grade 3 or 4 adverse events included neurologic toxicities, cytopenias lasting more than 28 days, infections, and febrile neutropenia.
Tisagenlecleucel suspension is marketed as Kymriah by Novartis.