By Sneha SK and Sriparna Roy
(Reuters) – The U.S. Food and Drug Administration said on Friday it had approved an injectable version of Bristol Myers (NYSE: ) Squibb’s hit cancer drug, Opdivo.
Opdivo is part of a class of drugs called PD-1 inhibitors, which increase the immune system’s ability to fight cancer by removing its natural brakes.
Like other PD-1 drugs such as Merck (NS:) Keytruda, was previously available by infusion, and patients received it through an intravenous drip in a health care practitioner’s office.
The new injectable form is expected to be more convenient for patients and could help protect the company from falling sales when the patent for the intravenous version expires later this decade.
The injection, branded as Opdivo Qvantig, is approved for the treatment of all previously approved indications for solid tumors in adults, either alone, as maintenance therapy or in combination with chemotherapy.
The drug will be available in early January and the price will be the same as the list price of the IV version, Adam Lenkowsky, Bristol’s chief pre-approval commercialiser, told Reuters.
The IV version of the drug has a list price of $7,635 per infusion for two weeks for the lower dose and $15,269 per infusion for four weeks for the higher dose of 480 milligrams.
The approval was based on data from a late-stage study, which showed that the subcutaneous form of the drug was non-inferior to the intravenous formulation in patients with advanced kidney cancer who had previously received systemic therapy.
The drugmaker is relying on newer treatments such as Opdivo Qvantig to fuel growth as patents on older drugs such as cancer drug Revlimid and blood thinner Eliquis expire later this decade.
Opdivo Qvantig is co-formulated with Halozyme Therapeutics (NASDAQ:)’ drug delivery technology, which helps reduce treatment administration from hours-long IV infusions to subcutaneous injections delivered in minutes.
