Eisai and Nuvation Bio have entered into an exclusive license and collaboration agreement to expand the global footprint of taletrectinib, a next-generation oral therapy for ROS1-positive Non-Small Cell Lung Cancer (NSCLC).

Under the agreement, Eisai gains exclusive rights to develop, register and commercialise taletrectinib in key markets across Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand and multiple Asia-Pacific countries, including India. Meanwhile, Nuvation Bio will retain full US commercial rights and continue to lead global development activities.

Taletrectinib, marketed as Ibtrozi in the US and Japan, is currently approved in the US, China and Japan for patients with advanced ROS1+ NSCLC. The therapy is a highly selective, CNS-active ROS1 inhibitor designed to address brain metastases, a major challenge in this patient population.

As part of the deal, Eisai will pay EUR 50 million upfront and up to EUR 145 million in regulatory and commercial milestone payments, along with double-digit tiered royalties on future net sales. An initial milestone payment of EUR 25 million is tied to EU regulatory approval. Eisai stated the agreement will not impact its consolidated financial forecast through March 31, 2026.

A Marketing Authorisation Application for taletrectinib in Europe is expected in the first half of 2026, followed by filings in Canada and other regions. The partnership builds on taletrectinib’s full U.S. FDA approval granted in June 2025, following Priority Review and Breakthrough Therapy designations.

Both companies highlighted the collaboration as a major step toward expanding global access to a potential new standard of care for patients with ROS1+ NSCLC, addressing a critical unmet need in lung cancer treatment.