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FDA Approves Injectable Form of Opdivo, Offering Greater Convenience for Cancer Patients

NextEdge Admin

28 Dec 2024

2 min 14 sec

The U.S. Food and Drug Administration has approved an injectable version of Bristol Myers Squibb's blockbuster cancer drug, Opdivo. Part of the PD-1 inhibitor class, Opdivo enhances the immune system's ability to combat cancer by removing natural inhibitory mechanisms. Previously available only as an intravenous (IV) infusion, the new injectable form, branded as Opdivo Qvantig, offers greater convenience by reducing administration time from hours to minutes.

Opdivo Qvantig has been approved to treat all adult solid tumor indications previously authorized for the IV formulation. It can be used alone, as maintenance therapy, or in combination with chemotherapy. The injectable form is expected to protect Bristol Myers Squibb's market share as the IV patent expires later this decade. The drug will launch in early January, priced equivalently to the IV version, which costs $7,635 for a two-week lower dose and $15,269 for a four-week higher dose.

The FDA's approval was based on a late-stage study demonstrating that the subcutaneous version is as effective as the IV formulation in treating advanced kidney cancer in patients who had undergone prior systemic therapy. The new formulation was co-developed with Halozyme Therapeutics using its proprietary drug delivery technology, streamlining treatment and improving patient convenience. As patents on older drugs like Revlimid and Eliquis near expiration, Bristol Myers Squibb anticipates Opdivo Qvantig and similar innovations will sustain its growth trajectory.