05:51 PM EST, 03/05/2024 (MT Newswires) -- Verastem ( VSTM ) said Tuesday the US Food and Drug Administration granted orphan drug designation to avutometinib for the treatment of low-grade serous ovarian cancer.
The treatment is on track for submission of a rolling new drug application for accelerated approval in H1 and a potential launch in 2025, the company said.
Low-grade serous ovarian cancer is "a highly recurrent, chemotherapy-resistant cancer, associated with slow tumor growth and high mortality rate," and the FDA has not approved any treatments for the disease, the company said.
Verastem ( VSTM ) said it is evaluating avutometinib and defactinib in the phase 3 study.
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