Taiho Pharmaceutical and Cullinan Therapeutics began a rolling New Drug Application filing with the FDA seeking accelerated approval of zipalertinib for patients with locally advanced or metastatic non‑small cell lung cancer harboring EGFR exon 20 insertion mutations after prior platinum chemotherapy. The drug’s Phase I/II dataset supports a priority review pathway and the sponsors aim to complete the submission by Q1 2026. Zipalertinib already holds FDA breakthrough therapy designation and could become an important oral option for this difficult‑to‑treat mutation subgroup.