Bristol Myers Squibb has won FDA approval for an injectable version of its blockbuster cancer immunotherapy Opdivo, a regulatory decision that gives patients a more convenient dosing option and provides the pharmaceutical giant a new way to fend off coming competition.
The pivotal test for injectable Opdivo evaluated the drug in renal cell carcinoma, but the approval announced late Friday spans all of the approved solid tumor indications covered by approvals for intravenously infused Opdivo as a monotherapy. BMS will market the new injectable drug as Opdivo Qvantig.
Opdivo belongs to the class of therapies called checkpoint inhibitors. The drug itself is an antibody designed to block PD-1, a checkpoint protein on immune cells that stops them from recognizing cancer cells. First approved in 2014 as a treatment for melanoma, the drug has gone on to win numerous approvals in additional cancers. In the first nine months of 2024, Opdivo, in all of its approved indications, accounted for $6.8 billion in sales. The immunotherapy is BMS’s top-selling cancer product.
Antibody drugs are typically administered as intravenous infusions; dosing of Opdivo takes about 30 minutes. BMS said an injection of Opdivo Qvantig takes three to five minutes. In a Phase 3 test that compared monthly injections of Opdivo Qvantig to every-two-week infusions of Opdivo as a treatment for advanced or metastatic clear cell renal cell carcinoma, results showed the injectable version met the main goal of achieving comparable exposure throughout the body and similar efficacy. Results also showed the new injectable version’s safety profile was comparable to that of Opdivo.
Beyond Opdivo Qvantig’s approval in all of the solid tumor indications for Opdivo, the new injectable product is approved as a monotherapy maintenance treatment after a patient has completed treatment with Opdivo plus Yervoy, a different BMS immunotherapy. The injectable version of Opdivo may also be used in combination with chemotherapy or the cancer drug cabozantinib. Opdivo Qvantig is not approved for use in combination with intravenously infused Yervoy.
“Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types,” Adam Lenkowski, BMS’s executive vice president and chief commercialization officer, said in a prepared statement. “With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.”
The faster delivery of Opdivo Qvantig is made possible by Enhanze, a drug delivery technology developed by biotech company Halozyme. Enhanze consists of an engineered enzyme that enables biologic drugs to be administered as subcutaneous injections. The key patent for Opdivo will expire in 2028, opening the door to competition from biosimilar versions of the IV infused drug. Opdivo Qvantig could help BMS retain some of its immunotherapy market share with a patent-protected alternative dosing option.
Other pharma giants are also pursuing subcutaneous dosing for their respective checkpoint inhibitors. In September, Roche won FDA approval for Tecentriq Hybreza, the injectable version of its PD-L1 inhibitor Tecentriq. Like Opdivo Qvantig, the Roche immunotherapy is made with Halozyme’s technology. Meanwhile, Merck last month posted positive Phase 3 data for an injectable version of its blockbuster PD-1 inhibitor, Keytruda. Injectable Keytruda employs enzyme technology from Alteogen.
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