The U.S. Food and Drug Administration (FDA) will review AstraZeneca and Merck‘s application seeking the extension of Lynparza (olaparib) tablets for the treatment of HER-negative metastatic breast cancer patients whose tumors carry a germline mutation in the BRCA gene.
The supplemental new drug application, meant for patients who have already received chemotherapy, has been granted priority review status. The FDA’s decision is expected by the first quarter of 2018.
Lynparza is an oral PARP inhibitor that is already approved for the treatment of recurrent ovarian cancer patients with inherited BRCA mutations who received three or more chemotherapy regimens. It is also approved as a maintenance therapy to prevent cancer from returning after platinum-based chemotherapy.
However, its mode of action suggested that the drug could also be positive in treating other cancers.
The recent submission was based on data from the OlympiAD Phase 3 trial (NCT02000622), which showed that the ovarian cancer therapy delayed cancer progression and death in BRCA mutated, HER2-negative metastatic breast cancer patients compared to standard chemotherapy.
The open-label, international trial, sponsored by AstraZeneca, enrolled 302 participants and randomly assigned them Lynparza tablets (300 mg twice daily) or a chemotherapy chosen by the physician — Xeloda (capecitabine), Navelbine (vinorelbine), or Halaven (eribulin). Only patients who received one to two prior chemotherapy regimens were eligible for the study.
Conducted by researchers at the Memorial Sloan Kettering Cancer Center and colleagues at other international institutions, the trial’s primary goal was to assess the time to disease progression or death, a measure called progression-free survival.
Median progression-free survival was significantly increased in patients treated with Lynparza, compared to those in the control group, at 7.0 months versus 4.2 months, respectively. This represented a 42% reduction in the risk of disease progression. Also, the response rate was higher in Lynparza-treated patients (59.9% vs. 28.8%).
Severe adverse events were more common in the chemotherapy arm than in the Lynparza arm, at 50.5% versus 36.6%, respectively. More patients in the chemotherapy group discontinued treatment.
The findings were published in The New England Journal of Medicine in a study titled, “Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation.”
“Among patients with HER2-negative metastatic breast cancer and a germline BRCA mutation, olaparib monotherapy provided a significant benefit over standard therapy,” the study concluded.
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