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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, utilizin
Cullinan Therapeutics has initiated a New Drug Application via the FDA Real-Time Oncology Review program for zipalertinib plus platinum chemotherapy in first-line EGFR exon 20 insertion NSCLC. This submission is based on Phase 3 REZILIENT3 trial data, which met its primary endpoint. The company anticipates completing t