Verastem Completes Rolling NDA Submission to US FDA for Drug Combination to Treat Rare Ovarian Cancer

MT Newswires Live11-01

Verastem (VSTM) said late Thursday that it has completed a rolling new drug application to the US Food and Drug Administration for the combination of avutometinib and defactinib to treat people with recurrent KRAS mutant low-grade serous ovarian cancer, who were given at least one previous systemic therapy.

The company said it has filed the application through the regulator's accelerated approval track and requested priority review due to the combination's potential to address significant unmet medical need among people with the disease.

The regulator's filing decision is expected before the end of of this year, with potential for regulatory approval by the middle of next year, Verastem said.

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