Taiho Pharmaceutical and Cullinan Therapeutics began filing a rolling NDA to the FDA for accelerated approval of zipalertinib, based on phase I/II data in NSCLC patients with EGFR exon 20 insertion mutations who previously received platinum chemotherapy. Zipalertinib holds a breakthrough therapy designation and the sponsors expect to complete submission in Q1 2026 to seek priority review. The filing targets a genomically defined population with limited targeted options and reflects continued regulatory pathways for mutation‑specific kinase inhibitors.