Cullinan Therapeutics Starts NDA Submission for Zipalertinib

Cullinan Therapeutics has initiated a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zipalertinib in combination with platinum-based chemotherapy. This submission targets first-line treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, utilizing the FDA's Real-Time Oncology Review (RTOR) program.