India, July 1 -- Cogent Biosciences Inc. (COGT), a biotechnology company, on Tuesday announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Bezuclastinib in treating advanced systemic mastocytosis.
Advanced Systemic Mastocytosis (AdvSM) is a rare type of blood neoplasms that leads to the excess proliferation of mast cells.
Bezuclastinib is a selective KIT inhibitor, that targets KIT mutations common in AdvSM patients. The drug was incorporated in an expanded access program for patients with Systemic Mastocytosis eligible for treatment with Bezuclastinib alone or Bezuclastinib in combination with sunitinib.
The NDA was supported by positive data from the pivotal Phase 3 APEX trial, whic...