Cogent Biosciences announcse U.S. BTD for bezuclastinib

Cogent Biosciences (COGT) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation, BTD, for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib. “We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We look forward to the continued collaboration with the FDA as we work to bring the first new treatment option in over twenty years to this patient population.”