FDA Approves 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 blockbuster cancer drug, Opdivo.

Opdivo belongs to a class of drugs known as PD-1 inhibitors, which bolster the immune system's ability to combat cancer by removing natural inhibitions. Previously, Opdivo was administered via intravenous infusions at healthcare facilities.

The new injectable formulation, branded as Opdivo Qvantig, is expected to offer greater convenience for patients and may help protect the company against potential sales declines when the intravenous version's patent expires later this decade.

Opdivo Qvantig has received approval for all previously sanctioned adult solid tumor indications, whether used alone, as maintenance therapy, or alongside chemotherapy. It will be available in early January and will be priced the same as the intravenous version, which has a list price of $7,635 per infusion for two weeks or $15,269 for four weeks at the higher 480-milligram dose.

The FDA's approval was informed by data from a late-stage study demonstrating that the subcutaneous formulation is not inferior to the intravenous version in patients with advanced kidney cancer who have undergone prior systemic therapy.

Bristol Myers Squibb aims to encourage growth through newer treatments, such as Opdivo Qvantig, as patents on older drugs like Revlimid and Eliquis approach expiration later this decade. The injectable was co-formulated with Halozyme Therapeutics' drug delivery technology, reducing treatment time from hours-long IV infusions to quick subcutaneous injections.