Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)
Cogent Biosciences submitted a New Drug Application (NDA) to the FDA for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM), supported by positive data from the pivotal APEX trial. The trial data showed an 81% objective response rate per PPR criteria and 65% per mIWG criteria, with durable 12-month PFS and OS rates of 79% and 87% respectively.
Key figures
- Orr ppr
- 81%
- Orr miwg
- 65%
- Os 12 month rate
- 87%
- Pfs 12 month rate
- 79%
- Advsm patients treated
- 81
- Kit d816v vaf reduction ge50
- 91%
- Serum tryptase reduction ge50
- 89%
- Bone marrow mast cell reduction ge50
- 89%
AI analysis
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