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# Priority Review for Verastem Ovarian Cancer NDA
- URL: https://www.fdaweb.com/priority-review-for-verastem-ovarian-cancer-nda/
- Published: 2025-01-08T12:00:00.000Z
- Updated: 2026-09-14T14:50:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158448

FDA has accepted for review a Verastem Oncology NDA for avutometinib, an oral RAF/MEK clamp for use in combination with defactinib, an oral FAK inhibitor, for treating adult patients with recurrent low-grade serous ovarian cancer (LGSOC) who received at least one prior systemic therapy and have a KRAS mutation. The agency accepted the NDA under its accelerated approval pathway and it granted a priority review with a user fee review action target date of 6/30, according to the company.

The submission was based on data from the the Phase 2 RAMP 201 clinical trial whose [results](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-presents-positive-updated-ramp-201-data&esheet=54171616&newsitemid=20241230294719&lan=en-US&anchor=results&index=1&md5=a67a2129bd99232dbc3b31eb12f7bb27&ref=fdaweb.com) were presented in an oral presentation at the International Gynecologic Cancer Society annual global meeting 10/2024\. The data demonstrated that the combination of avutometinib plus defactinib “resulted in a substantial overall response rate confirmed by blinded independent central review, with responses that were typically durable, and that the combination was generally well-tolerated in patients with recurrent KRAS mutant LGSOC,” according to the company.

Additionally, the company says it is currently enrolling patients with recurrent LGSOC regardless of KRAS mutation status for RAMP 301, an international Phase 3 trial that will serve as a confirmatory study for the initial indication and has the potential to support an expanded indication regardless of KRAS mutation status.