Bristol Myers Squibb received U.S. FDA approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme’s ENHANZE drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor. 

The subcutaneous administration of Opdivo Qvantig is faster, with a three- to five-minute administration time compared to 30 minutes for IV Opdivo. Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, may reduce steps required for preparation and time needed for administration.

The FDA approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which was a noninferiority trial evaluating Opdivo Qvantig co-formulated with Halozyme’s recombinant human hyaluronidase (rHuPH20), compared to intravenous Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy.  

In the trial, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 days and minimum concentration at steady state of Opdivo Qvantig vs. IV Opdivo.