FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection | FDA

The FDA has approved a new subcutaneous formulation of the cancer immunotherapy nivolumab, co-formulated with the peptide enzyme hyaluronidase-nvhy, under the brand name Opdivo Qvantig. This approval allows for injection under the skin rather than intravenous infusion across all solid tumor indications for adults. Clinical trials confirmed that the subcutaneous method provides comparable drug exposure and safety to the traditional IV infusion.