Otsuka units file for US approval for zipalertinib

Japanese drugmaker Otsuka’s (TYO: 4578) subsidiaries Taiho Oncology and Taiho Pharmaceutical, along with partner US Cullinan Therapeutics (Nasdaq: CGEM), have initiated the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking accelerated approval of zipalertinib.

The drug is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, intended for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations who have previously received platinum-based systemic chemotherapy.

Zipalertinib previously received Breakthrough Therapy designation in 2021, which with FDA agreement, allows submission of portions of the application as they are completed. The companies anticipate completion of the NDA submission in the first quarter of 2026 with an associated request for priority review.