Written by Sneha SK and Sriparna Roy
(Reuters) – The U.S. Food and Drug Administration said on Friday it has approved an injectable version of Bristol-Myers Squibb Inc.’s (BMY) blockbuster cancer drug Opdivo.
Opdivo is part of a class of drugs called PD-1 inhibitors, which strengthen the immune system’s ability to fight cancer by releasing the immune system’s natural brakes.
Like other PD-1 drugs, such as Merck’s Keytruda, it was previously available as an intravenous infusion, which patients received in a nurse’s office.
The new injection is expected to be more convenient for patients and could help the company avoid a drop in sales when the intravenous drug’s patent expires later this year.
The injectable drug, named Opdivo Kvantig, is approved to treat all previously approved adult solid tumor indications alone, either as maintenance therapy or in combination with chemotherapy.
Adam Lenkowski, Bristol’s chief commercial officer, told Reuters ahead of the approval that the drug would be available in early January and priced at the same price as the IV version.
List prices for the IV version of the drug are $7,635 per infusion over two weeks for the lower dose and $15,269 per infusion over four weeks for the higher dose of 480 milligrams.
The approval was based on data from a late-stage study that showed the subcutaneous version of the drug was noninferior to the intravenous version in patients with advanced kidney cancer who had previously received systemic therapy.
The company is relying on new treatments such as Opdivo Kvantig to fuel growth as patents on older drugs such as the cancer drug Revlimid and blood thinner Eliquis expire later this year.
Opdivo Qvantig is co-formulated with Halozyme Therapeutics’ drug delivery technology, which reduces treatment dosing from hours of IV infusions to subcutaneous injections administered in minutes.
(Reporting by Sneha SK and Sriparna Roy in Bengaluru; Editing by Pooja Desai, Shreya Biswas and Tasim Zahid)
