Verastem Oncology, a biopharmaceutical company, announced on Monday that the Food and Drug Administration (FDA) has prioritized its treatment for a rare ovarian cancer subtype, leading to a nearly 20% increase in the company's stock during after-hours trading. The FDA has accepted Verastem’s New Drug Application (NDA) for priority review under the accelerated approval process. This application involves avutometinib, an oral RAF/MEK inhibitor, combined with defactinib, an oral FAK inhibitor. This combination is intended for adult patients with recurrent low-grade serous ovarian cancer (LGSOC) who have previously undergone at least one systemic treatment and possess a KRAS mutation.
The NDA was submitted in October 2024, and the agency has set a Prescription Drug User Fee Act (PDUFA) target action date for June 30, 2025. Low-grade serous ovarian cancer is an uncommon form of this disease, affecting between 6,000 to 8,000 women in the United States and around 80,000 women globally. This cancer type is known for its high recurrence rate and reduced sensitivity to chemotherapy, with a typical survival rate of about ten years. Current treatments primarily include hormone therapy and chemotherapy, but there are no FDA-approved therapies specifically targeting LGSOC.
