The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for repotrectinib, a next-generation tyrosine kinase inhibitor, for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and for certain adult and pediatric patients with advanced solid tumors. The decision, announced by Bristol Myers Squibb (NYSE: BMY), marks a significant step toward providing a new treatment option in the EU for these patient populations, pending final approval by the European Commission expected in January 2025.
The CHMP's recommendation stems from the outcomes of the TRIDENT-1 and CARE clinical trials. These studies demonstrated that repotrectinib yielded clinically meaningful response rates and durable activity in patients, including intracranial responses and those with common resistance mutations. The safety profile was reported as generally manageable with routine care.
Clinical Trial Data and Efficacy
The TRIDENT-1 trial, an ongoing global Phase 1/2 study, is evaluating repotrectinib in advanced solid tumors, including NSCLC with ROS1 and NTRK fusions. The CARE trial focuses on pediatric and young adult patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 gene alterations. These trials aim to further assess long-term outcomes and additional endpoints.
Repotrectinib has already received approval in the United States for similar indications. The U.S. Food and Drug Administration (FDA) granted approval for adult patients with advanced ROS1-positive NSCLC in November 2023 and for patients with NTRK-positive solid tumors in June 2024.
Disease Context and Unmet Needs
Lung cancer, particularly NSCLC, constitutes a significant portion of cancer diagnoses and is often aggressive. A subset of these patients exhibit ROS1 fusions. Similarly, NTRK gene fusions in solid tumors are rare but can lead to aggressive cancer growth. Targeted therapies like repotrectinib are potentially valuable in addressing these specific genetic drivers of cancer.
Bristol Myers Squibb's Perspective
Bristol Myers Squibb has expressed gratitude to the patients and investigators involved in the trials and anticipates the possibility of offering this treatment option in the EU. The recommendation by CHMP addresses the need for new treatments for these patient populations within the European Union.
Financial and Market Context
Bristol-Myers Squibb (NYSE: BMY) has a substantial market capitalization of $118.65 billion. The company's revenue for the last twelve months as of Q3 2024 stood at $47.44 billion, with a revenue growth of 5.56% over the same period. BMY has maintained dividend payments for 54 consecutive years, with a current dividend yield of 4.1%.
