Verastem Reports the US FDA’s NDA Acceptance of Avutometinib Plus Defactinib to Treat Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer (LGSOC)
Shots:
- The US FDA has accepted & granted priority review (PDUFA: Jun 30, 2025) to NDA of avutometinib + defactinib for treatment-experienced KRAS-mutated recurrent LGSOC adults, under accelerated approval pathway. Launch is expected in mid-2025
- NDA was based on P-I (FRAME) trial & P-II (RAMP 201) trial of avutometinib (3.2mg, BIW) ± defactinib (200mg, BID) in LGSOC patients, identifying the combination as go-forward treatment in Part A; Parts B & C will assess the regimen’s safety & efficacy & Part D will explore low-dose regimen
- P-II showed significant ORRs & good tolerability. The P-III (RAMP 301) study will confirm results for this indication & is recruiting LGSOC patients regardless of KRAS mutations for indication expansion
Ref: Verastem | Image: Verastem
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