Approval of Injectable Opdivo

By Sneha S K and Sriparna Roy

(Reuters) – The U.S. Food and Drug Administration has approved an injectable version of Bristol Myers Squibb’s cancer drug, Opdivo.

Opdivo is categorized as a PD-1 inhibitor, enhancing the immune system’s ability to combat cancer by releasing its natural restraints.

Previously available only through intravenous infusion, the injectable form aims to provide greater convenience for patients and protect sales as the intravenous version’s patent nears expiration.

Branded as Opdivo Qvantig, the injection is approved for previously sanctioned adult solid tumor indications, used alone, as maintenance therapy, or alongside chemotherapy.

Launch is set for early January, with pricing aligned to the intravenous version, which costs $7,635 for a lower 480-milligram dose over two weeks, and $15,269 for a higher dose over four weeks.

The FDA’s decision stemmed from late-stage study data demonstrating that the subcutaneous version was not inferior to the intravenous formulation for advanced kidney cancer patients who had received previous systemic therapy.

Bristol aims for growth through innovative treatments like Opdivo Qvantig as patents on older drugs such as Revlimid and Eliquis expire later this decade. The new variant leverages Halozyme Therapeutics’ delivery technology, transforming lengthy IV infusions into quick subcutaneous injections, completing treatment in minutes.