FDA Accepted NDA Priority Review of Verastem Oncology’s Avutometinib

December 31, 2024

DENVER, Colo., Dec 31, 2024 (247marketnews.com)- Verastem Oncology (NASDAQ: VSTM) reported that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for avutometinib combined with defactinib, 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 was completed in October 2024 and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025, with the FDA asserting that it does not plan to hold an advisory committee meeting to discuss the application.

Dan Paterson, Verastem Oncology’s president and CEO, commented, “The FDA filing acceptance and Priority Review for the combination of avutometinib and defactinib underscores the critical unmet need among patients diagnosed with this rare and insidious disease. We are excited by today’s news and to potentially bring the first ever FDA-approved treatment specifically for recurrent KRAS mutant LGSOC to patients in the U.S.

“With the acceptance of this NDA, we’re taking an important step forward in addressing a condition that has long been overlooked, and we look forward to working with the FDA during its review process and preparing for a commercial launch in mid-2025.”

If approved, the avutometinib and defactinib combination would be the first FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC.

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