Otsuka Files for New Lung Cancer Drug with FDA

Otsuka Holdings announced that its subsidiary, Taiho Pharmaceutical, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for dipatrelinib, a treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The application was initiated under the FDA’s Real-Time Oncology Review (RTOR) program, enabling early review of clinical data.

The NDA submission follows positive results from the Phase 3 REZILIENT3 trial, which demonstrated statistically significant and clinically meaningful progression-free survival improvements when dipatrelinib was combined with platinum-based chemotherapy. Otsuka identifies dipatrelinib as a key driver of future growth and considers this submission a significant step toward enhancing long-term corporate value. The company’s fiscal year 2026 consolidated earnings forecast remains unchanged at this time.

The RTOR program allows companies to submit clinical data before completing the full application dossier. Otsuka expects to complete the NDA submission by year-end 2026. A separate NDA for dipatrelinib as a single agent is currently under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027. EGFR ex20ins mutations are present in up to 4% of NSCLC cases globally and as many as 12% of EGFR-mutated NSCLC cases in the U.S.