Approval of Injectable Opdivo

By Sneha S K and Sriparna Roy

(Reuters) – The U.S. Food and Drug Administration announced on Friday its approval of an injectable version of Bristol Myers Squibb’s blockbuster cancer drug, Opdivo.

Opdivo belongs to a class of medications known as PD-1 inhibitors, which enhance the immune system’s ability to combat cancer by removing its natural brakes.

Previously available only through intravenous infusions in healthcare settings, the new injectable formulation is anticipated to be more convenient for patients, potentially safeguarding the company’s sales against erosion when the patent for the IV version expires later this decade.

Branded as Opdivo Qvantig, the injection has been approved for treatment of all previously authorized adult solid tumor indications, either independently, as maintenance therapy, or in combination with chemotherapy.

Expected to be available in early January, it will be priced in line with the intravenous version. Adam Lenkowsky, Bristol’s chief commercialization officer, informed Reuters that the IV drug has a list price of $7,635 per infusion for the lower dose over two weeks and $15,269 for a higher 480-milligram dose administered over four weeks.

The approval was supported by data from a late-stage study, demonstrating that the subcutaneous form of the drug was not inferior to the intravenous formulation in patients with advanced kidney cancer who had undergone prior systemic therapy.

Bristol Myers Squibb is looking to newer treatments like Opdivo Qvantig to promote growth as patents expire on older products, including cancer drug Revlimid and blood thinner Eliquis, later this decade.

Opdivo Qvantig was co-formulated with Halozyme Therapeutics’ drug delivery technology, which shortens treatment administration from hours-long IV infusions to subcutaneous injections delivered in minutes.