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European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

Bristol Myers Squibb has released a new Press Release announcing that the European Medicines Agency (EMA) has validated the marketing authorization application for repotrectinib. Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) intended for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The application is based on data from the TRIDENT-1 and CARE trials, demonstrating robust responses and durable activity in these patient populations.

If approved, repotrectinib could potentially become a best-in-class treatment option for patients in the European Union with these specific types of cancer. The press release provides details about the ongoing trials, the safety profile of repotrectinib, and its potential benefits for patients facing high unmet medical needs. The announcement also mentions that the U.S. Food and Drug Administration (FDA) has already approved repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The press release concludes with information about Bristol Myers Squibb’s commitment to cancer research and the development of innovative therapies.

Read the full Press Release here