By Connor Hart
Bristol Myers Squibb received approval from the Food and Drug Administration for its treatment of certain cancers.
The Princeton, N.J., company said Friday approval for the subcutaneous injection treatment, Opdivo Qvantig, is based on the results from a Phase 3 trial, which compared the drug to an existing intravenous treatment in adult patients with advanced or metastatic clear cell renal cell carcinoma, who had received prior systemic therapy.
The trial demonstrated non-inferior co-primary pharmacokinetic exposures, similar efficacy in overall response rate and showed a comparable safety profile, the company said.
Bristol Myer's treatment offers faster administration, as it can be delivered in three-to-five minutes, according to medical oncologist Saby George, who directs network clinical trials at Roswell Park Comprehensive Cancer Center. This quicker delivery may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home, he added.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
12-27-24 1812ET