Posted by Michael Wonder on 28 May 2026
Cogent Biosciences announces FDA acceptance of new drug application with priority review for bezuclastinib in combination with sunitinib for patients with GIST
28 May 2026 - New drug acceptance acceptance with priority review builds upon previous assignment of breakthrough therapy designation and real-time oncology review following Phase 3 PEAK results; PDUFA date set for 30 November 2026.
Cogent Biosciences today announced that the US FDA has accepted its new drug application for bezuclastinib in combination with sunitinib for patients with gastro-intestinal stromal tumours who have received prior treatment with imatinib.
