Bristol Myers Squibb (BMY) announced on Friday that the U.S. Food and Drug Administration has granted approval for Opdivo Qvantig (a combination of nivolumab and hyaluronidase-nvhy) for subcutaneous injection. This newly approved formulation combines nivolumab with recombinant human hyaluronidase (rHuPH20) and is authorized for use in nearly all previously approved solid tumor indications for Opdivo in adults. It can be used as monotherapy, as maintenance therapy following completion of Opdivo plus Yervoy (ipilimumab) combination treatment, or in conjunction with chemotherapy or cabozantinib.
The FDA's decision was informed by findings from the Phase 3 CheckMate-67T trial, a randomized, open-label study. This trial evidenced that subcutaneous administration of Opdivo Qvantig has comparable pharmacokinetic exposures, demonstrated similar efficacy in terms of overall response rate (ORR), and presents a safety profile akin to that of intravenous (IV) Opdivo.
With this new approval, Opdivo Qvantig becomes the first and only PD-1 inhibitor to be administered subcutaneously, providing a more rapid treatment option. The subcutaneous method allows for administration in just three to five minutes, a notable improvement over the 30-minute duration required for IV Opdivo, according to Bristol Myers Squibb.
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