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The U.S. Food and Drug Administration (FDA) has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, marking a significant advancement in the treatment of a wide range of solid tumors in adults. This approval applies to the majority of previously authorized adult solid tumor indications for Opdivo (nivolumab), providing an alternative, faster method of administration.
Opdivo Qvantig is a combination product that pairs nivolumab with recombinant human hyaluronidase, a substance that aids in the delivery of the medication. The new formulation will be available for use both as a monotherapy, as well as part of combination therapies, including Opdivo plus Yervoy (ipilimumab) or alongside chemotherapy or cabozantinib. Notably, Opdivo Qvantig will also be available as a maintenance therapy following completion of the Opdivo plus Yervoy regimen.
This approval follows the results of the Phase 3 randomized, open-label CheckMate-67T trial, which showed that Opdivo Qvantig was noninferior to intravenous Opdivo on key pharmacokinetic measures, including time-averaged concentration over 28 days and minimum concentration at steady state. Additionally, the trial demonstrated that Opdivo Qvantig achieved an overall response rate of 24 percent, compared to 18 percent for intravenous Opdivo.
Adam Lenkowsky, Executive Vice President and Chief Commercialization Officer at Bristol Myers Squibb, expressed optimism about the approval, stating, “Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types. With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.”
The approval of subcutaneous Opdivo Qvantig was granted to Bristol Myers Squibb, the pharmaceutical company behind the development of this innovative treatment.
For more information, visit Bristol Myers Squibb News.
