Otsuka Holdings Co., Ltd.
Commencement of NDA Submission under FDA RTOR Program for Zipareltinib Combined with Chemotherapy as First-line Treatment for NSCLC with EGFR Exon 20 Insertions
Taisho Pharmaceutical has initiated an NDA submission under the FDA RTOR program for zipareltinib (targeting EGFR ex20ins) in combination with platinum-based chemotherapy. There is no change to consolidated earnings guidance for the fiscal year ending December 2026 at this time. The program is positioned as a mid- to long-term growth driver. NDA submission is expected to be completed by the end of 2026.
Key Figures
- Planned NDA Completion Timing: Expected to be completed by the end of 2026
- Interim Analysis Results: In the 2026 Q3 REZILIENT3 trial met primary endpoint, showing improvement in progression-free survival
- Regulatory Authority: FDA, Target Review Date: 2027-02-27 (PDUFA based)
AI要約
Start of NDA Submission and Indication
Taisho Pharmaceutical, a 100% subsidiary of Otsuka Holdings Co., Ltd., has commenced submission of a New Drug Application (NDA) under the FDA Real-Time Oncology Review (RTOR) program for zipareltinib in combination with platinum-based chemotherapy for untreated, locally advanced or metastatic NSCLC patients harboring EGFR exon 20 insertions. Zipareltinib is currently under development, and the NDA review is progressing with a target action date of February 27, 2027.
Business Strategy and Outlook
Zipareltinib is positioned as an important mid- to long-term growth driver to enhance corporate value, and if the NDA is approved it is expected to drive the company’s growth. There is currently no change to consolidated earnings guidance for the fiscal year ending December 2026; any material new disclosures will be announced as they arise.
Otsuka Holdings Co., Ltd.
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