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NEWS
Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer
Verastem Oncology (VSTM) has completed its rolling New Drug Application (NDA) to the FDA for avutometinib plus defactinibcombination therapy for adults with recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). The company is seeking accelerated approval and priority review, with a potential FDA approval decision by mid-2025. The Phase 2 RAMP 201 study showed promising results with a 44% confirmed overall response rate, 22 months median progression-free survival, and 70% disease control rate at 6 months in KRAS mutant LGSOC patients. If approved, this would be the first FDA-approved treatment specifically for this rare cancer type.
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