FDA approves Verastem's AVMAPKI FAKZYNJA for KRAS-mutated recurrent LGSOC

Verastem, Inc.

First-ever FDA-approved treatment for KRAS-mutated recurrent LGSOC; accelerated approval based on Phase 2 RAMP 201.
RAMP 201 showed 44% overall response rate (BIRC) in 57 patients; median duration of response range 3.3–31.1 months.
Approval granted May 8, 2025, ahead of the June 30 PDUFA date; continued approval contingent on confirmatory trial.
AVMAPKI FAKZYNJA CO-PACK expected to be commercially available in the U.S. within one week.
Verastem to host investor call at 2:30 pm ET today to discuss the approval.

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