Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). This combination product pairs nivolumab with recombinant human hyaluronidase (rHuPH20) and is set to be used in most previously approved adult solid tumor indications for Opdivo as monotherapy, following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
CHECKMATE-67T Study Results Influence FDA Decision
The FDA’s decision was informed by the results from the CHECKMATE-67T study, which demonstrated non-inferior co-primary pharmacokinetic (PK) exposures and similar efficacy in overall response rate (ORR) for Opdivo Qvantig compared to intravenous (IV) Opdivo. The study showed a comparable safety profile between the two forms of administration. Specifically, noninferiority was established for the co-primary endpoints of time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) of Opdivo Qvantig versus IV Opdivo.
Enhanced Efficacy and Rapid Administration
The overall response rate, a key powered secondary endpoint, was 24% in the Opdivo Qvantig arm, compared with 18% in the IV Opdivo arm, indicating a potential enhancement in efficacy. Moreover, Opdivo Qvantig offers a faster administration process, with the drug being delivered in just three to five minutes, a significant improvement over traditional IV administration times.-Fineline Info & Tech
