Verastem Oncology's Ovarian Cancer Treatment Gets FDA Priority Review

(RTTNews) - Biopharmaceutical company Verastem Oncology (VSTM) Monday said that its treatment for a rare form of ovarian cancer has been given priority review by the Food and Drug Administration. Following the news, shares of Verastem jumped nearly 20% in after-hours session.

The U.S. Food and Drug Administration has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy and have a KRAS mutation.

The NDA, completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025.

Low-grade serous ovarian cancer, or LGSOC, is a rare form of ovarian cancer that affects around 6,000 to 8,000 women in the U.S. and approximately 80,000 globally. This cancer which is highly recurrent and less sensitive to chemotherapy has a median survival of approximately ten years. The current standard treatment for this disease involves hormone therapy and chemotherapy. However, there are no therapies specifically approved by the FDA for LGSOC.