A version of Bristol Myers Squibb’s breakthrough cancer drug by injection, Opdivo Qvantig, has been approved by the US Food and Drug Administration (FDA) on Friday, reported Reuters on Dec 28.
The cancer-drug injection has been approved to treat all previously approved adult, solid tumor indications, either on its own, as maintenance therapy or in combination with chemotherapy.
The drug will be available in early January 2025, and will be priced at parity with the list price of the IV version, according to Bristol.
The IV version injection of 240 mg every two weeks has a list price of $7,635 (about RM34,113) per infusion; Opdivo injection 480 mg given every four weeks has a list price of $15,269 (about RM68,222).
The approval was based on data from a late-stage study, which showed that the the drug by injection was not inferior to the intravenous formulation in patients with advanced kidney cancer who have received prior systemic therapy.
Opdivo Qvantig was co-formulated with Halozyme Therapeutics’ drug delivery technology, which helps reduce treatment administration from hours-long IV infusions to subcutaneous injections delivered in minutes.
Opdivo is part of a class of drugs called PD-1 inhibitors, which enhance the immune system’s ability to fight cancer by removing its natural brakes.
Like other PD-1 drugs, such as Merck’s Keytruda, it was previously available through infusion and patients received it via an intravenous drip.
The new drug by injection is expected to be more convenient for patients and could help shield the company from erosion of sales when the patent for older drugs expires later this decade, such as cancer drug Revlimid and blood thinner Eliquis.
