Cogent to initiate New Drug Application submission for bezuclastinib

Cogent Biosciences (COGT) announced that the U.S. Food and Drug Administration, FDA, has agreed to accept its New Drug Application, NDA, for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors, GIST, who have received prior treatment with imatinib under the Real-Time Oncology Review, RTOR, program. “This milestone reflects the FDA’s recognition of the significant unmet need facing patients with imatinib resistant GIST,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Based on positive results from the PEAK trial, the bezuclastinib combination has the potential to be the first new approval in this patient population in over 20 years. We look forward to the continued, close collaboration with the FDA as we advance bezuclastinib toward commercialization.”