Eisai Co., Ltd. and Nuvation Bio Inc. have announced a long-term exclusive license and collaboration agreement for the drug taletrectinib. Already approved for advanced non-small cell lung cancer (NSCLC) in the U.S, China, and Japan, under the new agreement, Eisai will now have exclusive development, registration and commercialization rights for taletrectinib, in Europe and several other regions. The territories include the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam, and India.
David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, described this partnership as a major global expansion milestone for taletrectinib. He affirmed the company’s belief in Eisai’s capability to accelerate the opportunity for providers and patients around the world to access this important treatment option, owing to Eisai’s world-class infrastructure and a successful track record of launching innovative medicines across major regions.
The agreement entails that Eisai will pay EUR 50 million (approximately USD 60 million) upfront and up to EUR 145 million (approximately USD 170 million) in regulatory and commercial milestone payments. Eisai also agrees to pay double-digit tiered royalties up to the high-teens as a percentage of future net sales in the licensed territories. The first milestone payment of EUR 25 million (approximately USD 30 million) from this transaction is set to be made upon the achievement of EU regulatory approval (conditional or full) of taletrectinib.
Terushige Iike, Chief Business Officer of Eisai Co., Ltd., expressed the company’s excitement regarding the partnership and highlighted the potential of taletrectinib to become a standard of care for patients with ROS1+ NSCLC in the EU and beyond. A Marketing Authorization Application (MAA) for the treatment of advanced ROS1+ NSCLC is expected to be filed in Europe in the first half of 2026, and additional filings are then planned for Canada and other regions.
The U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy in June 2025. In Japan, the drug is marketed by Nippon Kayaku, and in China, it is marketed by Innovent Biologics under the brand Dovbleron.