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Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisat
About this update from Eisai Co., Ltd.
[{"type":"text","content":"The Marketing Authorisation Application (MAA) has been validated and accepted for full approval consideration with a standard review timeline","length":141,"tagName":"p","attribs":{}},{"type":"text","content":"Additional filings are planned for the U.K., Canada and other regions included in Eisai's licensed territories ","length":114,"tagName":"p","attribs":{}},{"type":"text","content":"Taletrectinib is already approved in the U.S., China and Japan for advanced ROS1-positive non-small cell lung cancer","length":116,"tagName":"p","attribs":{}},{"type":"text","content":"TOKYO and NEW YORK, March 26, 2026 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline.","length":754,"tagName":"p"},{"type":"image","alt":"Nuvation Bio Inc.; Eisai Co., Ltd. logo","displaySize":"","headline":null,"caption":"Nuvation Bio Inc.; Eisai Co., Ltd. logo","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":225,"url":"https://media.zenfs.com/en/prnewswire.com/2131fe95f8f961230a0035a0fa73ddda"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/eg5HeiUAg19g5AvZQcHCIA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM5Nw--/https://media.zenfs.com/en/prnewswire.com/2131fe95f8f961230a0035a0fa73ddda","width":400,"height":225}},"href":"https://mma.prnewswire.com/media/2943511/Nuvation_Bio_Eisai_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Taletrectinib (marketed as IBTROZI® in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries...