Verastem Oncology Granted FDA Orphan Drug Designation For Avutometinib In Ovarian Cancer

(RTTNews) - Verastem Oncology (VSTM) said that the U.S. Food and Drug Administration granted Orphan Drug Designation to avutometinib, a RAF/MEK clamp, alone or in combination with defactinib, a selective FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer or LGSOC.

The company said it is rapidly advancing the development program for avutometinib and defactinib in low-grade serous ovarian cancer with its ongoing Phase 3 clinical trial to deliver the new combination treatment to patients as quickly as possible. It remains on track to begin submission of an NDA to the FDA for Accelerated Approval of this combination in the first half of 2024 and preparing for a potential launch in 2025.

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