Ipsen: positive opinion in advanced renal carcinoma

(CercleFinance.com) - Ipsen has announced that the CHMP, the Scientific Committee of the European Medicines Agency, has recommended the approval of Cabometyx, in combination with Opdivo from Bristol Myers Squibb, for the first-line treatment of advanced renal cell carcinoma.


The European Commission, which is empowered to approve drugs in the EU, will now review the CHMP's recommendation and is expected to communicate its final decision in the coming months regarding the approval of the combination therapy in the EU.

This positive opinion is based on the pivotal Phase III CheckMate-9ER study, which demonstrated clinically significant benefits in terms of progression-free survival, overall survival and objective response rate compared to sunitinib.


Copyright (c) 2021 CercleFinance.com. All rights reserved.