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EU regulators to fast-track Janssen’s multiple myeloma CAR-T

April 04, 2019 / Richard Staines

European regulators are to hasten development of Janssen’s CAR-T therapy for patients with multiple myeloma, after promising early-stage trial results. Janssen, the pharma arm of Johnson & Johnson, said the European Medicines Agency has granted a PRIME (PRIority MEdicines) designation for the investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-4528. Janssen has been developing the CAR-T previously known as LCAR-B38M with China’s Legend Biotech following a deal signed in December 2017. US biotech bluebird bio and partner Celgene are competitors and have two BCMA CAR-T therapies in early stage development for multiple myeloma, while Amgen’s AMG 420 has also emerged as a potential contender with some spectacular remission rates in a small trial announced last September.