Business
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
PRINCETON, N.J. & TOKYO & CAMBRIDGE, Mass., April 28, 2026--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 locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on
About this update from Cullinan Therapeutics, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1024,"height":512,"url":"https://media.zenfs.com/en/business-wire.com/28b2073049d30380514820fabd831bed"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/BQs0h_hRdRSzuEdDmdGV4A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQ4MA--/https://media.zenfs.com/en/business-wire.com/28b2073049d30380514820fabd831bed","width":960,"height":480},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/a._r20_LJV5s8.dyue4luQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwNDg7aD0xMDI0/https://media.zenfs.com/en/business-wire.com/28b2073049d30380514820fabd831bed","width":1024,"height":512}},"lazy":false},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1024,"height":512,"url":"https://media.zenfs.com/en/business-wire.com/114fb2286bc74250efbf106a49fd1d5f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/phgXN9r_6RwO7baP6gKJAA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQ4MA--/https://media.zenfs.com/en/business-wire.com/114fb2286bc74250efbf106a49fd1d5f","width":960,"height":480},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/AZ9_76RkG1bRlUE9Yv4mmQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwNDg7aD0xMDI0/https://media.zenfs.com/en/business-wire.com/114fb2286bc74250efbf106a49fd1d5f","width":1024,"height":512}}},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1024,"height":512,"url":"https://media.zenfs.com/en/business-wire.com/3c325f17a1c5909cd6c0832e73058edc"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/6R339Ms.f.vx5giODYu75g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQ4MA--/https://media.zenfs.com/en/business-wire.com/3c325f17a1c5909cd6c0832e73058edc","width":960,"height":480},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/.I5jAvMcgluDFPgSg7LFbQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwNDg7aD0xMDI0/https://media.zenfs.com/en/business-wire.com/3c325f17a1c5909cd6c0832e73058edc","width":1024,"height":512}}},{"type":"list","items":[{"val":[{"type":"text","content":"NDA submission based on the Phase 2b REZILIENT1 clinical trial, which demonstrated clinically meaningful and durable responses in patients with relapsed EGFR exon 20 insertion–mutated NSCLC","...