Merck has announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committee’s guidance but takes its advice into consideration. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.

Neal Shore, chief medical officer of urology and surgical oncology for GenesisCare, US and PROpel trial investigator, said, “Today’s recommendation by the ODAC is disappointing news for clinicians and prostate cancer patients alike. Preventing or delaying radiographic progression is an important clinical endpoint in assessing oncologic treatment and is very relevant to patients, their caregivers and their families. It is essential that physicians and their patients have an opportunity to choose treatment with the goal of optimizing cancer care outcomes.”

Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said, “Novel treatments are urgently needed for patients with metastatic castration-resistant prostate cancer. While we are pleased with the recognition of the benefit of LYNPARZA plus abiraterone for patients with BRCA-mutated metastatic castration-resistant prostate cancer, we are disappointed with the outcome of today’s ODAC meeting. We strongly believe in the results of the PROpel trial, which demonstrated a clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.”

Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “With the incidence and mortality of prostate cancer set to double in the coming decades, it is critical that we bring new treatment options with the potential to reduce the risk of disease progression or death to patients at the earliest possible moment in their care. Though we are pleased that the ODAC recommended LYNPARZA for patients with mCRPC who have BRCA mutations, we believe in the potential of LYNPARZA plus abi/pred for a broad range of patients with mCRPC, based on the results of PROpel. We look forward to the outcome of the FDA’s review of the application.”