China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).
Somerset, N.J.—November 21, 2022—Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared Legend Biotech’s Investigational New Drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric […]
Seven accepted poster presentations showcase our continued leadership in CAR-T cell therapy research for patients with multiple myelomaNew analysis of sustained minimal residual disease (MRD) negativity from the pivotal CARTITUDE-1 study of CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) in heavily pretreated adults with relapsed or refractory multiple myeloma (RRMM)First conference presentation of data from the CARTIFAN-1 study of cilta-cel in […]
SOMERSET, N.J., – September 27, 2022 – Legend Biotech Corporation (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved CARVYKTI™ (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for […]
First investigational product being recommended for Breakthrough Therapy Designation in China SOMERSET, NJ, August 5, 2020 – Legend Biotech Corporation (NASDAQ: LEGN) announcedtoday that the China Center for Drug Evaluation, National Medical Products Administration(CDE, NMPA) has recommended Breakthrough Therapy Designation (BTD) for ciltacabtageneautoleucel (cilta-cel; LCAR-B38M CAR-T cells), an investigational B-cell maturation antigen(BCMA) targeted chimeric antigen […]
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