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FDA Approvals in Cervical Cancer, Ovarian Cancer, and CLL, and More

Gina Columbus
Published: Friday, Jun 15, 2018



Today-

FDA approvals in cervical cancer, ovarian cancer, and chronic lymphocytic leukemia, a priority review designation in breast cancer, a European approval in non–small cell lung cancer, and a label update in multiple myeloma.

Welcome to OncLive News Network! I’m Gina Columbus.

In cervical cancer, the FDA granted an accelerated approval to pembrolizumab for the treatment of patients with advanced, PD-L1–positive disease with progression on or after chemotherapy.

The decision is based on findings from the international, global, open-label, multicenter phase II KEYNOTE-158 trial, which evaluated pembrolizumab in patients with multiple types of advanced solid tumors who have progressed on standard therapy.

At median follow-up of 11.7 months, the overall response rate was 14.3% in 77 PD-L1–positive patients who previously received at least 1 line of chemotherapy in the metastatic setting. The ORR comprised a complete response rate of 2.6% and a partial response rate of 11.7%.

The accelerated approval for pembrolizumab in this setting is contingent on the results of a confirmatory trial.

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In ovarian cancer, the FDA has approved bevacizumab for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of women with advanced disease following initial surgical resection.

The decision is based on findings from the phase III GOG-0218 trial, in which the bevacizumab regimen reduced the risk of disease progression or death by 38% versus chemotherapy alone. The median progression-free survival was 18.2 months versus 12.0 months, respectively.

In the final overall survival analysis, the median OS was 43.8 months with bevacizumab and chemotherapy followed by bevacizumab, versus 40.6 months with chemotherapy alone.

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The FDA has granted a standard approval to the BCL-2 inhibitor venetoclax for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, following at least 1 prior therapy. Venetoclax is now also approved for use in combination with rituximab in the same patient population.

The approval is based on the phase III MURANO trial, in which the median progression-free survival at 23 months' median follow-up was not reached with venetoclax plus rituximab compared with 18.1 months with bendamustine plus rituximab. The overall response rate was 92% versus 72%, respectively.

In April 2016, the FDA granted an accelerated approval to venetoclax for patients with CLL/SLL harboring a 17p deletion, following at least 1 prior therapy.

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In breast cancer, the FDA has granted a priority review to a new drug application for talazoparib for the treatment of patients with germline BRCA mutation–positive, HER2-negative locally advanced or metastatic disease.

The application is based on the phase III EMBRACA trial, in which talazoparib reduced the risk of disease progression or death by 46% compared with chemotherapy in patients with BRCA-positive advanced breast cancer.

Results showed that at a median follow-up of 11.2 months, the median progression-free survival was 8.6 months with talazoparib versus 5.6 months with physician’s choice of therapy. Additionally, the objective response rate was 62.6% versus 27.2%, respectively.

The FDA is scheduled to make its decision on the NDA by December 2018, under the Prescription Drug User Fee Act. Pfizer, the manufacturer of talazoparib, also reported that the European Medicines Agency has accepted an application for the use of talazoparib in the same patient population.

*********************************

The European Commission has granted an approval to osimertinib as a frontline treatment for patients with EGFR-mutant locally advanced or metastatic non–small cell lung cancer.

In the double-blind, phase III FLAURA study, frontline osimertinib was found to reduce the risk of progression or death by 54% versus erlotinib or gefitinib. The median progression-free survival was 10.2 months for standard tyrosine kinase inhibitor therapy and 18.9 months with osimertinib.

Osimertinib was approved by the FDA in April 2018 for this first-line indication, following its initial approval in 2015 for pretreated patients with EGFR T790M-positive NSCLC.

*****************************************

In multiple myeloma, the FDA approved a supplemental new drug application to add overall survival data from the phase III ASPIRE trial to the label for carfilzomib for use in patients with relapsed/refractory multiple myeloma.

In the study, the combination of carfilzomib, lenalidomide, and dexamethasone reduced the risk of death by 21% versus lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma following 1 to 3 prior lines of treatment.

The median OS with the carfilzomib combination was 48.3 months versus 40.4 months with lenalidomide and dexamethasone alone. The OS benefit seen at the final analysis was consistent even in patients who received prior treatment with bortezomib.

In addition to the ASPIRE findings, carfilzomib also showed an OS benefit in the phase III ENDEAVOR study. In January 2018, the FDA approved an sNDA adding OS data from the ENDEAVOR trial to the label for carfilzomib.

************************************

This week, we sat down with Dr Stephen Schuster of the University of Pennsylvania to discuss the response data from the JULIET trial in patients with diffuse large B-cell lymphoma.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Today-

FDA approvals in cervical cancer, ovarian cancer, and chronic lymphocytic leukemia, a priority review designation in breast cancer, a European approval in non–small cell lung cancer, and a label update in multiple myeloma.

Welcome to OncLive News Network! I’m Gina Columbus.

In cervical cancer, the FDA granted an accelerated approval to pembrolizumab for the treatment of patients with advanced, PD-L1–positive disease with progression on or after chemotherapy.

The decision is based on findings from the international, global, open-label, multicenter phase II KEYNOTE-158 trial, which evaluated pembrolizumab in patients with multiple types of advanced solid tumors who have progressed on standard therapy.

At median follow-up of 11.7 months, the overall response rate was 14.3% in 77 PD-L1–positive patients who previously received at least 1 line of chemotherapy in the metastatic setting. The ORR comprised a complete response rate of 2.6% and a partial response rate of 11.7%.

The accelerated approval for pembrolizumab in this setting is contingent on the results of a confirmatory trial.

*********************************

In ovarian cancer, the FDA has approved bevacizumab for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of women with advanced disease following initial surgical resection.

The decision is based on findings from the phase III GOG-0218 trial, in which the bevacizumab regimen reduced the risk of disease progression or death by 38% versus chemotherapy alone. The median progression-free survival was 18.2 months versus 12.0 months, respectively.

In the final overall survival analysis, the median OS was 43.8 months with bevacizumab and chemotherapy followed by bevacizumab, versus 40.6 months with chemotherapy alone.

*********************************

The FDA has granted a standard approval to the BCL-2 inhibitor venetoclax for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, following at least 1 prior therapy. Venetoclax is now also approved for use in combination with rituximab in the same patient population.

The approval is based on the phase III MURANO trial, in which the median progression-free survival at 23 months' median follow-up was not reached with venetoclax plus rituximab compared with 18.1 months with bendamustine plus rituximab. The overall response rate was 92% versus 72%, respectively.

In April 2016, the FDA granted an accelerated approval to venetoclax for patients with CLL/SLL harboring a 17p deletion, following at least 1 prior therapy.

*********************************

In breast cancer, the FDA has granted a priority review to a new drug application for talazoparib for the treatment of patients with germline BRCA mutation–positive, HER2-negative locally advanced or metastatic disease.

The application is based on the phase III EMBRACA trial, in which talazoparib reduced the risk of disease progression or death by 46% compared with chemotherapy in patients with BRCA-positive advanced breast cancer.

Results showed that at a median follow-up of 11.2 months, the median progression-free survival was 8.6 months with talazoparib versus 5.6 months with physician’s choice of therapy. Additionally, the objective response rate was 62.6% versus 27.2%, respectively.

The FDA is scheduled to make its decision on the NDA by December 2018, under the Prescription Drug User Fee Act. Pfizer, the manufacturer of talazoparib, also reported that the European Medicines Agency has accepted an application for the use of talazoparib in the same patient population.

*********************************

The European Commission has granted an approval to osimertinib as a frontline treatment for patients with EGFR-mutant locally advanced or metastatic non–small cell lung cancer.

In the double-blind, phase III FLAURA study, frontline osimertinib was found to reduce the risk of progression or death by 54% versus erlotinib or gefitinib. The median progression-free survival was 10.2 months for standard tyrosine kinase inhibitor therapy and 18.9 months with osimertinib.

Osimertinib was approved by the FDA in April 2018 for this first-line indication, following its initial approval in 2015 for pretreated patients with EGFR T790M-positive NSCLC.

*****************************************

In multiple myeloma, the FDA approved a supplemental new drug application to add overall survival data from the phase III ASPIRE trial to the label for carfilzomib for use in patients with relapsed/refractory multiple myeloma.

In the study, the combination of carfilzomib, lenalidomide, and dexamethasone reduced the risk of death by 21% versus lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma following 1 to 3 prior lines of treatment.

The median OS with the carfilzomib combination was 48.3 months versus 40.4 months with lenalidomide and dexamethasone alone. The OS benefit seen at the final analysis was consistent even in patients who received prior treatment with bortezomib.

In addition to the ASPIRE findings, carfilzomib also showed an OS benefit in the phase III ENDEAVOR study. In January 2018, the FDA approved an sNDA adding OS data from the ENDEAVOR trial to the label for carfilzomib.

************************************

This week, we sat down with Dr Stephen Schuster of the University of Pennsylvania to discuss the response data from the JULIET trial in patients with diffuse large B-cell lymphoma.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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