Bristol Myers Squibb has received FDA approval for an injectable model of its blockbuster most cancers immunotherapy Opdivo, a regulatory determination that provides sufferers a extra handy dosing choice and gives the pharmaceutical large a brand new strategy to fend off coming competitors.
The pivotal check for injectable Opdivo evaluated the drug in renal cell carcinoma, however the approval introduced late Friday spans all the authorized strong tumor indications lined by approvals for intravenously infused Opdivo as a monotherapy. BMS will market the brand new injectable drug as Opdivo Qvantig.
Opdivo belongs to the category of therapies known as checkpoint inhibitors. The drug itself is an antibody designed to dam PD-1, a checkpoint protein on immune cells that stops them from recognizing most cancers cells. First authorized in 2014 as a remedy for melanoma, the drug has gone on to win quite a few approvals in extra cancers. Within the first 9 months of 2024, Opdivo, in all of its authorized indications, accounted for $6.8 billion in gross sales. The immunotherapy is BMS’s top-selling most cancers product.
Antibody medication are usually administered as intravenous infusions; dosing of Opdivo takes about half-hour. BMS stated an injection of Opdivo Qvantig takes three to 5 minutes. In a Part 3 check that in contrast month-to-month injections of Opdivo Qvantig to every-two-week infusions of Opdivo as a remedy for superior or metastatic clear cell renal cell carcinoma, outcomes confirmed the injectable model met the primary objective of attaining comparable publicity all through the physique and comparable efficacy. Outcomes additionally confirmed the brand new injectable model’s security profile was corresponding to that of Opdivo.
Past Opdivo Qvantig’s approval in all the strong tumor indications for Opdivo, the brand new injectable product is authorized as a monotherapy upkeep remedy after a affected person has accomplished remedy with Opdivo plus Yervoy, a special BMS immunotherapy. The injectable model of Opdivo may be utilized in mixture with chemotherapy or the most cancers drug cabozantinib. Opdivo Qvantig shouldn’t be authorized to be used together with intravenously infused Yervoy.
“Over the past decade, Opdivo has developed as an immunotherapy choice utilized in many indications throughout tumor varieties,” Adam Lenkowski, BMS’s govt vice chairman and chief commercialization officer, stated in a ready assertion. “With this new choice, we stay up for additional serving to most cancers sufferers with an administration technique that provides them quicker supply.”
The quicker supply of Opdivo Qvantig is made potential by Enhanze, a drug supply know-how developed by biotech firm Halozyme. Enhanze consists of an engineered enzyme that permits biologic medication to be administered as subcutaneous injections. The important thing patent for Opdivo will expire in 2028, opening the door to competitors from biosimilar variations of the IV infused drug. Opdivo Qvantig may assist BMS retain a few of its immunotherapy market share with a patent-protected different dosing choice.
Different pharma giants are additionally pursuing subcutaneous dosing for his or her respective checkpoint inhibitors. In September, Roche received FDA approval for Tecentriq Hybreza, the injectable model of its PD-L1 inhibitor Tecentriq. Like Opdivo Qvantig, the Roche immunotherapy is made with Halozyme’s know-how. In the meantime, Merck final month posted constructive Part 3 knowledge for an injectable model of its blockbuster PD-1 inhibitor, Keytruda. Injectable Keytruda employs enzyme know-how from Alteogen.
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