hapabapa/iStock Editorial via Getty Images Bristol Myers Squibb ( NYSE: BMY ) announced Friday that the EU drug regulator, the European Medicines Agency (EMA), validated its request to expand the approval for its cancer therapy Opdivo (nivolumab) to include a subcutaneous formulation. The PD-1 immune checkpoint inhibitor is already approved in the region as an intravenous infusion for several forms of solid tumors as a single agent or in combination with other medications, such as BMY’s CTLA-4-blocking antibody, Yervoy. With its marketing application, Bristol Myers ( BMY ) seeks EU approval to launch a subcutaneous nivolumab formulation developed using a drug delivery technology from Halozyme Therapeutics ( NASDAQ: HALO ) for multiple solid tumors in adults.
The marking application is based on data from the company’s Phase 3 CheckMate-67T trial, which indicated that subcutaneously delivered Opdivo worked as well as intravenous Opdivo in patients with a form of kidney cancer called renal cell carcinoma. More on Bristol-Myers Squibb Bristol-Myers Squibb: Move Investing Time Horizon To 2025, At Least Bristol-Myers Squibb: Could This Be A Value Trap? (Technical Analysis) Bristol-Myers Squibb Company (BMY) Goldman Sachs 45th Annual Global Healthcare Conference EU to require additional cancer risk labeling on CAR T therapies Bristol Myers gets FDA approval for Augtyro for NTRK-positive cancers.