The FDA accepted a supplemental New Drug Application for olaparib’s (Lynparza) new indication for first-line maintenance treatment of advanced ovarian cancer.
Officials with the FDA have accepted Merck’s supplemental New Drug Application (sNDA) for olaparib (Lynparza) for priority review, marking the first FDA submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor for first-line maintenance treatment of advanced ovarian cancer, according to a Merck press release.
If approved, this will also be the fourth indication for olaparib in the United States, Merck announced.
Olaparib is currently indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status and for the treatment of patients with advanced ovarian cancer with a germline BRCA mutation previously treated with 3 or more lines of chemotherapy.
The submission was based on data from the phase 3 SOLO-1 trial, which evaluated the safety and efficacy of olaparib tablets, 300 mg twice daily, as a maintenance monotherapy in 391 newly-diagnosed patients with BRCA-mutated advanced ovarian cancer following platinum-based chemotherapy. In the trial, olaparib showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with a placebo.
Patients received either olaparib or placebo for up to 2 years or until disease progression. According to the data, olaparib reduced the risk of disease progression or death by 70%. The median PFS for patients treated with olaparib was not reached compared with 13.8 months for patients treated with placebo at a median follow up of 41 months. The study showed that 60% of patients receiving olaparib remained progression-free at 36 months compared with 27% of patients in the placebo arm.
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