Cullinan Therapeutics announces U.S. FDA accepted NDA for zipalertinib

Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics (CGEM) announced that the U.S. Food and Drug Administration, FDA, has accepted a New Drug Application, NDA, for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, NSCLC, with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act, PDUFA target action date is February 27, 2027.