Verastem initiates rolling NDA for avutometinib/defactinib; RAMP 201 median duration 9 months

Verastem, Inc.

Rolling NDA for avutometinib+defactinib in recurrent KRAS mutant LGSOC started May 2024; priority review requested.
RAMP 201 interim data (Feb 2024 cutoff): median duration 9 months; KRAS mt 14 months, KRAS wt 7 months; 31/58 KRAS mt still on treatment.
Estimated addressable market: annual ~$300M KRAS mt, ~$270M KRAS wt; prevalent ~$1.7B KRAS mt, ~$1.1B KRAS wt based on $34k/month cost.
GenFleet collaboration: IND cleared June 2024, first patient dosed in China Phase 1/2 for KRAS G12D inhibitor GFH375/VS-7375.

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