The U.S. Food and Drug Administration has granted accelerated approval to Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The decision gives patients a new option in a heavily pre-treated setting where treatment choices are limited. Regulators based the clearance on results from the single-arm, mid-stage LINKER-MM1 study, in which 70 % of participants experienced tumor shrinkage and 45 % achieved a complete response. Lynozyfic targets the BCMA antigen on myeloma cells and the CD3 receptor on T-cells, making it the first bispecific antibody to earn FDA authorisation that combines those two specificities. Regeneron said it is working to make the drug available "as quickly as possible" and set a wholesale acquisition cost of US$470 per 5 mg vial and US$18,800 per 200 mg vial. The company is also exploring use of the agent in earlier treatment lines, positioning it against Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio, the other BCMA-directed myeloma bispecifics on the U.S. market. The American Cancer Society expects more than 36,000 new cases of multiple myeloma in the United States next year, with roughly 4,000 patients estimated to fall into the fifth-line or later category addressed by Lynozyfic.