FDA Streamlines Review of Cogent Biosciences' Bezuclastinib in ASM
核心洞察
The FDA has accepted Cogent Biosciences' New Drug Application for bezuclastinib in advanced systemic mastocytosis (搜索) and set a PDUFA action date of June 29, 2027.
The agency indicated no current plans for an advisory committee and reported no identified review issues for the advanced systemic mastocytosis (搜索) filing.
The submission is supported by pivotal APEX trial data showing clinically meaningful responses and durable clinical activity, with parallel reviews ongoing in nonadvanced SM and GIST (搜索).
Cogent Biosciences has announced that the FDA accepted its New Drug Application for bezuclastinib in advanced systemic mastocytosis (搜索) (AdvSM). The agency set a PDUFA action date of June 29, 2027, and indicated no current plans for an advisory committee, with no review issues identified.
The filing is based on pivotal APEX trial data showing clinically meaningful responses and durable clinical activity in AdvSM. Cogent is also pursuing parallel NDA reviews of bezuclastinib in nonadvanced systemic mastocytosis (搜索) and in GIST (搜索), a program the company frames as addressing multiple KIT (搜索)-driven diseases. Earlier PDUFA dates are in place for nonadvanced SM in December 2026 and for GIST in November 2026, alongside ongoing Expanded Access Programs.
Source: Yahoo Finance