FDA Approves Injectable Opdivo Qvantig Cancer Drug

The U.S. Food and Drug Administration (FDA) announced on Friday the approval of Bristol Myers Squibb's (BMS) injectable cancer drug Opdivo Qvantig. Opdivo, a PD-1 inhibitor, works by blocking the immune system’s natural inhibitory mechanisms, enhancing its ability to attack cancer. Previously, Opdivo was only available through intravenous infusion, requiring patients to undergo IV administration at medical facilities.

The new injectable form is expected to provide convenience for patients and help protect the company’s sales as patents for the IV version near expiration. Branded as Opdivo Qvantig, the new formulation has been approved for all previously authorized adult solid tumor indications and can be used alone or in combination with chemotherapy.

Before FDA approval, Bristol’s Chief Commercialization Officer Adam Lenkowsky told Reuters that the drug is expected to launch in early January, with pricing equivalent to the IV version. The IV version is priced at $7,635 per low-dose injection for two weeks and $15,269 for 480 mg per injection every four weeks.

The approval was based on late-stage study data showing that the subcutaneous version of Opdivo is comparable in effectiveness to the IV form in patients with advanced kidney cancer who had received prior systemic therapy.

Given the upcoming patent expirations of older drugs like cancer treatment Revlimid and blood thinner Eliquis, Bristol Myers Squibb is relying on new therapies like Opdivo Qvantig to drive growth. Co-developed with Halozyme Therapeutics, Opdivo Qvantig employs a novel drug delivery technology that reduces treatment time from hours of infusion to just minutes of subcutaneous injection.