[Opinion] CHMP Recommends Approval of Subcutaneous Nivolumab in Multiple Solid Tumors

Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications

PRINCETON, N.J.--(BUSINESS WIRE)--Mar 28, 2025-

EU’s CHMP Has Positive Opinion for Subcutaneous Nivolumab in Solid Tumors

Data from the phase 3 CheckMate-67T trial support the CHMP’s recommendation for approving subcutaneous nivolumab across various solid tumor indications.

CHMP Recommends Approval of Subcutaneous Nivolumab in Multiple Solid Tumors

Meta: The CHMP has recommended the European approval of subcutaneous nivolumab in solid tumors.

CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer's drug

Bristol Myers Squibb, BeiGene, AstraZeneca and Pfizer secured European backing for label expansions, and a French pharma got its first drug approval recommendation, in a list of actions by the European Medicines Agency’s human medicines ...