The U.S. Meals and Drug Administration has accredited Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use for many beforehand accredited grownup, strong tumor Opdivo (nivolumab) indications.
Opdivo Qvantig is a mixture product of nivolumab coformulated with recombinant human hyaluronidase. This approval is for many beforehand accredited grownup, strong tumor Opdivo indications as monotherapy, monotherapy upkeep following completion of Opdivo plus Yervoy (ipilimumab) mixture remedy, or together with chemotherapy or cabozantinib.
The approval relies on outcomes from the section 3 randomized, open-label CheckMate-67T trial, which demonstrated noninferiority for the coprimary finish factors of time-averaged focus over 28 days and minimal focus at a gradual state of Opdivo Qvantig versus intravenous Opdivo. Moreover, the trial confirmed an general response fee for Opdivo Qvantig of 24 % versus 18 % within the intravenous Opdivo arm.
“Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types,” Adam Lenkowsky, government vice chairman and chief commercialization officer at Bristol Myers Squibb, stated in an announcement. “With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.”
Approval of subcutaneous Opdivo Qvantig was granted to Bristol Myers Squibb.
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FDA approves subcutaneous opdivo qvantig for many strong tumor indications (2025, January 3)
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