On 27 December 2024, BMS announced that the US FDA has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20). The approval covers most (but not all) previously approved adult, solid tumour Opdivo® indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
Notable limitations of this approval include that Opdivo Qvantig® is not indicated in combination with ipilimumab for treatment of renal cell carcinoma, unresectable or metastatic melanoma, metastatic NSCLC, unresectable advanced or metastatic ESCC.
This approval makes Opdivo Qvantig® the first and only subcutaneously administered PD-1 inhibitor.