- The European Commission has approved the subcutaneous formulation of Opdivo (nivolumab) for use across multiple solid tumor indications.
- Opdivo SC is the first PD-1 inhibitor approved for subcutaneous use in the European Union, offering a quicker and more convenient treatment option for patients.
- The approval is backed by results from the CheckMate -67T trial demonstrating noninferiority to the intravenous formulation.
Bristol Myers Squibb (BMY, Financial) has announced that the European Commission (EC) has approved the subcutaneous (SC) formulation of Opdivo® (nivolumab), making it the first PD-1 inhibitor approved for subcutaneous use within the European Union. This formulation offers a new route of administration as a solution for injection in a 600 mg/vial strength.
The approval is based on Phase 3 results from the CheckMate -67T clinical trial, which demonstrated that the subcutaneous formulation of Opdivo® was noninferior to its intravenous version on the co-primary endpoints of average serum concentration over 28 days (Cavgd28) and minimum steady state concentration (Cminss). The trial also showed a consistent efficacy profile with the secondary endpoint of overall response rate.
Opdivo SC has been approved for use in multiple adult solid tumors either as monotherapy, monotherapy maintenance following intravenous nivolumab plus Yervoy® (ipilimumab) therapy, or in combination with chemotherapy or cabozantinib. The EC's decision permits the drug's use across the EU's 27 member states, as well as Iceland, Liechtenstein, and Norway.
Previously, on December 27, 2024, the U.S. Food and Drug Administration (FDA) approved subcutaneous nivolumab and hyaluronidase-nvhy, marketed under the brand Opdivo Qvantig™, for similar indications.
This approval marks a significant milestone for cancer treatment, providing patients with a more convenient and faster administration method, potentially improving the overall patient experience.
