Verastem's Ovarian Cancer Drug Application Accepted by FDA, Gets Priority Review

MT Newswires Live

Dec 31, 2024

Verastem (VSTM) said Monday that the US Food and Drug Administration accepted for review the new drug application for avutometinib in combination with defactinib for the treatment of patients with recurrent low-grade serous ovarian cancer that received at least one systemic treatment and have KRAS mutation.

The FDA granted priority review to the new drug application and has set an action date of June 30, according to the company.

There are currently no approved treatments for low-grade serous ovarian cancer, Verastem added.

The new drug application is based on results from the Phase 2 Ramp 201 study that showed avutometinib plus defactinib had a substantial overall response rate.

Shares of the company were up 22% in recent after-hours activity.

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