Approval based on noninferior pharmacokinetic exposures, similar effectiveness and safety to intravenous Opdivo
By Lori Solomon HealthDay Reporter
FRIDAY, Jan. 3, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use for most previously approved adult, solid tumor Opdivo (nivolumab) indications.
Opdivo Qvantig is a combination product of nivolumab coformulated with recombinant human hyaluronidase. This approval is 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 is based on results from the phase 3 randomized, open-label CheckMate-67T trial, which demonstrated noninferiority for the coprimary end points of time-averaged concentration over 28 days and minimum concentration at a steady state of Opdivo Qvantig versus intravenous Opdivo. Additionally, the trial showed an overall response rate for Opdivo Qvantig of 24 percent versus 18 percent in the intravenous Opdivo arm.
“Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types,” Adam Lenkowsky, executive vice president and chief commercialization officer at Bristol Myers Squibb, said in a statement. “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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