Crizotinib

A Marketing Authorisation Application with the European Medicines Agency is also under regulatory review for approval June 29, 2026 -- Nuvation Bio (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has validated the Marketing Authorisation Application (MAA) submitted by its partner Eisai Co, Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The application was submitted through the International Recognition Procedure, which takes into account approvals from trusted regulatory partners and supports expedited access to medicines in the U.K. The application will now be evaluated by the MHRA to decide whether to approve or reject the application. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Taletrectinib is an oral treatment for patients living with advanced ROS1+ NSCLC (marketed as IBTROZI ® in the U.S. and Japan). In March 2026, the European Medicines Agency validated the MAA for taletrectinib. Additional filings are planned for Canada and other regions included in Eisai's licensed territories. Within the U.K., there are around 50,200 new lung cancer cases every year. Around 80 to 85% of all lung cancers are NSCLC, of which approximately 2% of patients harbor the ROS1+ mutation. The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were originally published in the Journal of Clinical Oncology in April 2025, and updated data reflecting longer patient follow-up were presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2026, further building the efficacy and safety profile observed to date. Updated results from the TRUST-I study were also simultaneously published in April 2026 in the Journal of Clinical Oncology. "We are pleased to see taletrectinib advance into the regulatory review process in the U.K. following the recent progress with the EMA," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "Having seen the meaningful impact taletrectinib has already brought to patients in the U.S., China and Japan, we are excited about this important step in expanding access to this medicine. This validation brings us closer to delivering taletrectinib to patients in the U.K. and reinforces our commitment to making it available to patients around the world." In June 2025, 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, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON®. * Eisai's licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases. Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. IRP is a regulatory pathway established by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) that allows the agency to take into account the expertise and decision-making of trusted international reference regulators, such as the European Medicines Agency (EMA) and FDA. Under IRP, MHRA conducts a targeted assessment based on existing regulatory evaluations, with the aim of supporting patients in the U.K. with expedited access to safe and effective medicines. Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston and Shanghai. The content above comes from the network. if any infringement, please contact us to modify.