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News 2026-10-01 23:32 UTC

Cullinan Therapeutics Starts FDA NDA for Zipalertinib Combo

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