The U.S. Food and Drug Administration (FDA) recently approved Opdivo Qvantig, a new injectable formulation of Bristol Myers Squibb’s (BMY) leading cancer drug, Opdivo. This approval marks a significant advancement in cancer treatment, offering patients a more convenient alternative to intravenous infusions.
Opdivo belongs to a class of drugs known as PD-1 inhibitors, which work by boosting the immune system’s ability to detect and destroy cancer cells. These inhibitors essentially release the brakes on the immune system, allowing it to mount a more effective attack against tumors. Previously, Opdivo, like other PD-1 inhibitors such as Merck’s Keytruda, was only available as an intravenous infusion, requiring patients to receive treatment in a healthcare setting over an extended period.
This new subcutaneous injection, Opdivo Qvantig, is expected to significantly improve the patient experience. By eliminating the need for lengthy infusions, the injectable form offers greater flexibility and convenience, potentially reducing the burden of treatment. This shift could also help Bristol Myers Squibb maintain its market share as the patent for the intravenous version of Opdivo nears expiration later this decade.
The FDA’s approval covers all previously approved adult indications for solid tumors, allowing Opdivo Qvantig to be used as a standalone therapy, as maintenance therapy, or in combination with chemotherapy. The drug is slated for release in early January and will be priced comparably to the intravenous version, according to Adam Lenkowsky, Bristol Myers Squibb’s chief commercialization officer. The current list price for intravenous Opdivo is $7,635 per infusion for a lower dose administered every two weeks, and $15,269 per infusion for a higher 480-milligram dose given every four weeks.
The approval of Opdivo Qvantig is based on positive results from a late-stage clinical trial. The study demonstrated that the subcutaneous formulation was not inferior to the intravenous formulation in patients with advanced kidney cancer who had received prior systemic therapy. This finding provides strong evidence supporting the efficacy and safety of the new injectable option.
Bristol Myers Squibb is increasingly relying on innovative treatments like Opdivo Qvantig to fuel future growth. This strategic move comes as patents on key revenue-generating drugs, such as the cancer drug Revlimid and the blood thinner Eliquis, are set to expire in the coming years. Developed in collaboration with Halozyme Therapeutics, Opdivo Qvantig leverages Halozyme’s innovative drug delivery technology. This technology enables the transition from hours-long intravenous infusions to subcutaneous injections that can be administered in minutes, significantly streamlining the treatment process.
In conclusion, the FDA’s approval of Opdivo Qvantig represents a notable milestone in cancer care. This new injectable formulation offers a more convenient and potentially less burdensome treatment option for patients battling various types of solid tumors. The approval also positions Bristol Myers Squibb for continued success in the oncology market as it navigates patent expirations on older drugs.
