MHRA approval for BMS’ SC Opdivo

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) in a new formulation associated with a different route of administration (subcutaneous use), an alternative pharmaceutical form (solution for injection) and a new strength (600mg/vial).

Nivolumab for subcutaneous use is co-formulated with recombinant human hyaluronidase (rHuPH20) and is indicated across multiple adult solid tumors, approved prior to 2025, for administration every two or four weeks: as monotherapy; as monotherapy maintenance following completion of nivolumab plus ipimumab combination therapy; and in combination with chemotherapy or cabozantinib. Subcutaneous nivolumab will be provided by the National Health Service (NHS) England, the company noted.

In its current form, Opdivo is already BMS’ best-selling product, generating full-year 2024 sales of $9.3 billion. The subcutaneous formulation was cleared in the USA in December last year.