NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb (BMY) announced Friday that the U.S. Food and Drug Administration has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use. This combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20) is approved for most previously approved adult solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
The approval was based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which demonstrated non-inferior co-primary pharmacokinetic (PK) exposures, similar efficacy in overall response rate (ORR), and showed a comparable safety profile vs. intravenous (IV) Opdivo.
With this approval, Opdivo Qvantig is now the first and only subcutaneously administered PD-1 inhibitor, offering a faster delivery for patients to receive this immunotherapy treatment option in three to five minutes compared to 30-minute IV Opdivo, the company said.
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