BioCentury
ARTICLE | Regulation

CHMP’s recommendations for June

June 26, 2021 12:46 AM UTC

Along with a positive opinion for Opdivo nivolumab to treat adult patients with esophageal or gastroesophageal junction cancer, Bristol Myers Squibb Co. (NYSE:BMY) also received a recommendation from EMA’s CHMP for conditional approval of BCMA CAR T therapy Abecma idecabtagene vicleucel for relapsed and refractory multiple myeloma in adults who have received at least three prior therapies. Abcema is approved in the U.S. for relapsed or refractory MM after four lines of therapy.

Anti-VEGF-A mAb Byooviz ranibizumab from Samsung Bioepis Co. Ltd. is a biosimilar of Lucentis from Roche (SIX:ROG; OTCQX:RHHBY) and Novartis AG (NYSE:NVS; SIX:NOVN) that is under review for retinal vascular disorders. If approved by European Commission, it will be commercialized by Biogen Inc. (NASDAQ:BIIB) in Europe. A BLA for the therapy is under review by FDA...