New Drug Application Initiated for Zipalertinib Plus Chemotherapy for First-Line NSCLC with EGFR Exon 20 Insertion Mutation

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 is for the treatment of previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, and is being reviewed under the FDA's Real-Time Oncology Review (RTOR) program. The Phase 3 REZILIENT3 study demonstrated the longest median progression-free survival to date with this combination therapy in this patient population.