By Fineline Cube 
Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the European Commission (EC) has granted approval to the subcutaneous (SC) injection formulation of Opdivo (nivolumab) for the treatment of multiple adult solid tumors. The approved indications encompass Opdivo SC, co-formulated with recombinant human hyaluronidase (rHuPH20), for use as a monotherapy, maintenance monotherapy following combined intravenous (IV) Opdivo and Yervoy (ipilimumab) treatment, or in combination with chemotherapy or cabozantinib.
Approval Backed by Clinical Data
The positive decision from the EC was based on results from the CheckMate-67T clinical trial and additional supporting data. The trial demonstrated comparable pharmacokinetics (PK) and safety profiles between Opdivo SC and IV-administered Opdivo. Specifically, in adults with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had received no more than two prior systemic therapies and no prior immuno-oncology treatment, Opdivo SC met the primary PK endpoints of non-inferiority compared to IV Opdivo in Cavgd28 (28-day average steady-state concentration) and Cminss (steady-state trough concentration).
Opdivo SC: A First in the EU
Opdivo SC stands as the only approved subcutaneous PD-1 inhibitor in the European Union. This new formulation offers eligible patients a convenient administration option. Notably, in December 2024, the U.S. Food and Drug Administration (FDA) approved subcutaneous nivolumab and hyaluronidase-nvhy, marketed as Opdivo Qvantig, further expanding the drug’s availability globally.-Fineline Info & Tech