Bristol Myers Squibb Receives Positive CHMP Opinion for Repotrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer and Advanced NTRK-Positive Solid Tumors

Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity with repotrectinib in these patient populations

If approved, repotrectinib has the potential to be a best-in-class treatment for patients with advanced ROS1-positive non-small cell lung cancer in the European Union

Excerpt from the Press Release:

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC decision is expected in January 2025.

“Patients in the EU with ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors face a great unmet need for new therapies that may improve their outcomes and address or delay the difficult issue of treatment resistance,” said Joseph Fiore, vice president, global program lead, repotrectinib, Bristol Myers Squibb. “We look forward to the EC’s upcoming decision and to potentially bringing this next-generation treatment to patients with tumors harboring ROS1 or NTRK fusions in the EU.”

The positive opinion is based on results from the TRIDENT-1 and CARE trials, in which repotrectinib demonstrated clinically meaningful response rates in patients across ROS1-positive NSCLC and NTRK-positive solid tumor cohorts, both as an initial targeted treatment or after progression on a prior targeted treatment. Durability of response was robust and intracranial responses were observed in both settings, as well as in patients whose tumors harbor common resistance mutations.

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