FDA accepts drug application for zipalertinib lung cancer treatment
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U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
April 28, 2026 7:00 AM EDTNDA submission based on the Phase 2b REZILIENT1 clinical trial, which demonstrated clinically meaningful and durable responses in patients with relapsed EGFR exon 20 insertionmutated NSCLC Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027
PRINCETON, N.J. & TOKYO & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today 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... More
