Taiho finishes US filing for zipalertinib as FDA clears bladder combo

Taiho Oncology has finished submitting its New Drug Application to the FDA for zipalertinib (TAS6417/CLN-081) paired with platinum-based chemotherapy. Partner Cullinan Therapeutics announced the completion on November 12, and parent Otsuka Holdings followed with its own disclosure on the 13th. The filing targets previously untreated patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations, and it went in under the FDA's Real-Time Oncology Review framework, which lets trial data arrive early. This is a submission milestone, not an approval — the FDA sets its review deadline once it accepts the application.

The package rests on the Phase III REZILIENT3 trial, which hit its primary progression-free survival endpoint at an interim look. Data presented at WCLC 2026 showed median PFS of 14.5 months against 8.5 months, a hazard ratio of 0.50, and an objective response rate of 65.0% versus 40.3% across 279 randomized patients. Overall survival is still being tracked.

In Japan, KM Biologics said on November 13 that it filed for manufacturing and marketing approval of dried human blood coagulation factor X, known as KD-416. The intended indication is the bleeding tendency tied to factor X deficiency. A Phase I/III trial registered in the country's jRCT registry plans to test regular dosing, on-demand treatment for bleeds and perioperative use in congenital factor X deficiency, with 10 subjects planned — a headcount that signals how few patients live with the condition.

The FDA also cleared durvalumab (Imfinzi) plus enfortumab vedotin (Padcev) before surgery, followed by durvalumab alone afterward, for adults with muscle-invasive bladder cancer who can't take or opt out of cisplatin-based chemotherapy. The November 13 approval leans on the Phase III VOLGA trial of 695 patients, where median event-free survival wasn't reached in the combination arm versus 12.1 months in the surgery-only group, at a hazard ratio of 0.51, with an overall survival hazard ratio of 0.58. Regulators wrapped the priority review six weeks ahead of target and ran it through the international Project Orbis collaboration. Enfortumab vedotin is an Astellas Pharma product.