Cogent Biosciences submits bezuclastinib new drug application to the FDA

Cogent Biosciences (COGT) announced the completion of the submission of its new drug application to the FDA for bezuclastinib in patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier this year.