The FDA has accepted Cogent Biosciences’ new drug application for bezuclastinib for patients with advanced systemic mastocytosis and set a target action date of June 29, 2027.
The FDA has not identified potential review issues and does not plan to hold an advisory committee meeting at this time, Cogent said.
The application is supported by results from the APEX pivotal trial of bezuclastinib in advanced systemic mastocytosis. As of a March 31, 2026, data cutoff, the study reported a 65% overall response rate under modified International Working Group-Myeloproliferative Neoplasms Research and Treatment-European Competence Network on Mastocytosis criteria.
The company said 57% of patients had a complete remission, complete remission with partial hematologic recovery or partial remission as their best response. Under pure pathological response criteria, the response rate was 81%.
The 12-month progression-free survival rate was 79%, and the 12-month overall survival rate was 87%. Median progression-free and overall survival results were not yet mature, according to Cogent.
Bezuclastinib is a selective tyrosine kinase inhibitor designed to inhibit the KIT D816V mutation and other mutations in KIT exon 17. KIT D816V is associated with systemic mastocytosis, a disease involving proliferation of mast cells.
Cogent also has two other bezuclastinib applications under FDA review. Its application for nonadvanced systemic mastocytosis has a target action date of Dec. 30, 2026, and its application for gastrointestinal stromal tumors has a target action date of Nov. 30, 2026.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!