The U.S. Food and Drug Administration (FDA) has granted approval for an injectable formulation of Bristol Myers Squibb's (BMY) cancer drug, Opdivo, marking a significant advancement in patient convenience. This new subcutaneous version, branded as Opdivo Qvantig, offers a faster administration method compared to the traditional intravenous infusions.
Opdivo belongs to a class of drugs known as PD-1 inhibitors, which function by boosting the immune system’s ability to target and destroy cancer cells. Previously, Opdivo, similar to Merck's Keytruda, was administered through lengthy intravenous infusions at healthcare facilities.
The new injectable form is expected to reduce treatment time considerably, transitioning from hours-long infusions to minutes-long injections. This change is particularly aimed at improving patient experience and potentially safeguarding the company’s market share when the patent for the intravenous formulation expires.
Furthermore, Opdivo Qvantig is approved for all previously approved adult solid tumor indications, either as a standalone treatment, maintenance therapy, or in combination with chemotherapy. Bristol Myers Squibb has indicated that this new formulation will be available in early January, priced at parity with the existing intravenous version.
Clinical trial data, based on a late-stage study, demonstrated that the subcutaneous form of Opdivo was not inferior to the intravenous version in patients with advanced kidney cancer who had received prior systemic therapy. This crucial finding supported the FDA’s decision to approve the injectable alternative.
Bristol Myers Squibb is strategically focused on newer treatments like Opdivo Qvantig to sustain growth amidst patent expirations of older drugs, such as Revlimid and Eliquis. The injectable formulation utilizes Halozyme Therapeutics’ drug delivery technology, which facilitates the quicker, subcutaneous administration.
