Bristol Myers’ Opdivo subcutaneous formulation approved by European Commission

Bristol Myers (BMY) announced that the European Commission, or EC, has approved a new Opdivo – nivolumab – formulation associated with a new route of administration, a new pharmaceutical form – solution for injection – and a new strength, 600 mg/vial. Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase, has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The positive EC decision is based on results from the CheckMate -67T clinical trial and additional data that demonstrated comparable pharmacokinetics and safety profiles between Opdivo SC and IV Opdivo. The safety profile of Opdivo SC remained consistent with the IV formulation. The approval by the EC is valid in all 27 member states of the European Union, as well as Iceland, Liechtenstein and Norway. On December 27, 2024, subcutaneous nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, was approved by the FDA.