EC approval for BMS’ subcutaneous Opdivo

29 May 2025

The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).

Marketed by US pharma major Bristol Myers Squibb (NYSE: BMY), Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the subcutaneous formulation early this month, while the US Food and Drug Administration did so in December last year. Opdivo is already BMS’ best-selling product, generating full-year 2024 sales of $9.3 billion.

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