Bristol Myers: thumbs up for repotrectinib in EU
(CercleFinance.com) - Bristol Myers Squibb announces that it has received a positive opinion from the CHMP of the European Medicines Agency for its repotrectinib in the treatment of ROS1-positive advanced non-small cell lung cancer and NTRK-positive advanced solid tumors.
This recommendation is based on data from the TRIDENT-1 and CARE registration trials, which demonstrated robust responses and durable activity with repotrectinib in both these indications, in adults and over 12s respectively.
The European Commission, which has the power to approve drugs for the European Union, will now review the CHMP (Committee for Medicinal Products for Human Use) recommendation, with its final decision expected in January 2025.
If approved, repotrectinib has the potential to be a best-in-class treatment for patients with ROS1-positive non-small cell lung cancer in the European Union, Bristol Myers points out.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
This recommendation is based on data from the TRIDENT-1 and CARE registration trials, which demonstrated robust responses and durable activity with repotrectinib in both these indications, in adults and over 12s respectively.
The European Commission, which has the power to approve drugs for the European Union, will now review the CHMP (Committee for Medicinal Products for Human Use) recommendation, with its final decision expected in January 2025.
If approved, repotrectinib has the potential to be a best-in-class treatment for patients with ROS1-positive non-small cell lung cancer in the European Union, Bristol Myers points out.
Copyright (c) 2024 CercleFinance.com. All rights reserved.