Verastem initiates rolling NDA to FDA for avutometinib/defactinib in KRAS mutant LGSOC

Verastem, Inc.

Rolling submission of NDA seeking accelerated approval for recurrent KRAS mt LGSOC; initial sections include nonclinical and quality.
Clinical module to be submitted in H2 2024 with mature RAMP 201 data including 12-month follow-up; priority review to be requested.
As of Feb 2024 data cutoff: confirmed ORR by BICR 27% overall, 37% (KRAS mt, n=57) and 15% (KRAS wt, n=52); 60% clinical benefit rate ≥6 months.
Discontinuation due to AEs was 9%; median duration of therapy in Part A: 11 months overall, 18 months KRAS mt, 8 months KRAS wt.
No FDA-approved treatments exist for recurrent LGSOC; company plans focused commercial launch targeting top 400 HCPs with 14-18 reps.

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