Hematological Neoplasms

On March 16, 2024, Legend Biotech announced that the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) unanimously recommended, with a vote of 11:0, the approval of CARVYKTI® (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy (including a proteasome inhibitor and an immunomodulatory agent) and are refractory to lenalidomide.

On February 23, 2024, the European Medicines Agency (EMA) released the highlights of its meeting held from February 19-22.

Ciltacabtagene Autoleucel, a CAR-T product from China, received FDA approval in March 2022 and EU approval on May 26th of the same year, marking an unprecedented achievement.

On February 28, 2022, Legend Biotech Corporation (LEGN) announced that the U.S. Food and Drug Administration (FDA) has approved its first product, CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Dear readers, if you or someone around you is about to undergo CAR-T cell therapy, it is crucial to be well-prepared before the treatment.

Would you like to understand the entire process of CAR-T cell infusion? This comprehensive guide covers everything from pre-infusion preparation to infusion precautions and post-infusion management, ensuring you have a clear understanding and no longer feel lost! Read on!

On February 23, 2024, Legend Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval for the expanded indication of Carvykti (cilta-cel, ciltacabtagene autoleucel) to include the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy, including an immunomodulatory agent and a proteasome inhibitor.

Carvykti is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed or refractory multiple myeloma (R/R MM).