The FDA accepted a supplemental New Drug Application for olaparibâ€™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.
“Women with ovarian cancer are often diagnosed with advance disease, which unfortunately is associated with poor long-term survival rates,” co-principal investigator Kathleen Moore, associate director of Stephenson Cancer Center at The University of Oklahoma, said in a statement about the phase 3 study results. “The newly-diagnosed setting is our best opportunity to achieve a sustained remission, since once a patient’s ovarian cancer recurs, it is typically incurable.”
The safety profile of olaparib was in line with that observed in prior clinical trials. The most common adverse effects reported were nausea, fatigue, vomiting, anemia, and diarrhea. Seventy-one percent of patients on olaparib remained on the recommended starting dose and 88% of patients continued treatment without an adverse event-related discontinuation, according to the study.
A Prescription Drug User Fee Act date was set for the first quarter of 2019, according to the press release.
FDA Accepts Regulatory Submission for LYNPARZA (olaparib) Maintenance Therapy in Newly-Diagnosed, BRCA-Mutated Advanced Ovarian Cancer and Grants Priority Review [news release]. Merck’s website. https://www.mrknewsroom.com/news-release/oncology-newsroom/fda-accepts-regulatory-submission-lynparza-olaparib-maintenance-thera. Accessed November 12, 2018.
SOLO-1 Phase 3 Trial Demonstrates LYNPARZA (olaparib) Maintenance Therapy Cut the Risk of Disease Progression or Death by 70 Percent in Patients with Newly-Diagnosed, Advanced BRCA-Mutated Ovarian Cancer [news release]. Merck’s website. https://www.mrknewsroom.com/news-release/oncology-newsroom/solo-1-phase-3-trial-demonstrates-lynparza-olaparib-maintenance-thera. Accessed November 12, 2018.