Events Details
Taiho Oncology Announces FDA Acceptance of Zipalertinib Application for Advanced Lung Cancer
Wednesday, April 29, 2026
Taiho Oncology, along with Taiho Pharmaceutical and Cullinan Therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib.
NSCLC is the most common type of lung cancer. EGFR exon 20 insertion mutations account for up to 4% of global NSCLC cases and represent one of the more challenging subtypes to treat, with limited options currently available.
Zipalertinib is an oral EGFR tyrosine kinase inhibitor designed to target specific EGFR exon 20 insertion mutations while limiting effects on normal EGFR. It previously received Breakthrough Therapy Designation from the FDA in 2021 for this patient group.
REZILIENT1 is an ongoing Phase 1/2 clinical trial assessing the safety and effectiveness of zipalertinib in adults with advanced NSCLC carrying EGFR exon 20 insertion mutations. Patients received 100 mg twice daily, with outcomes assessed using standard tumour response criteria.
The drug is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy, with or without prior amivantamab. A regulatory decision is expected by 27 February 2027.
The application is supported by results from the Phase 2b portion of the REZILIENT1 trial, which evaluated zipalertinib as a single therapy in previously treated patients with EGFR exon 20 insertion-mutated NSCLC. The study met its main goal by showing a meaningful objective response rate. Findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.
In the main study group of 176 patients, including those previously treated with amivantamab, the confirmed objective response rate was 35%, with a median duration of response of 8.8 months. Among patients treated only with prior platinum-based chemotherapy (125 patients), the response rate was 40%, with the same median duration of response.
Further subgroup analysis showed a 30% response rate and a longer median response duration of 14.7 months in patients previously treated with amivantamab alone. Patients with brain metastases had a response rate of 31% and a median response duration of 8.3 months.
The treatment showed a manageable safety profile consistent with earlier findings. Most side effects were mild to moderate and included nail infections, rash, anaemia, acne-like skin reactions, diarrhoea, dry skin, nausea and inflammation of the mouth.
Source: taihooncology.com
