Author Archives: Marta Figueiredo

Darzalex Delays Disease Progression After ASCT, Phase 3 Trial Reports

First-line maintenance therapy with Darzalex (daratumumab) significantly delays disease progression or death in adults with multiple myeloma who responded to autologous stem cell transplant (ASCT), according to data from the CASSIOPEIA trial’s second part. These findings, from a pre-planned interim analysis conducted by an independent data monitoring committee, indicate that the Phase 3…

Cilta-cel, CAR T-cell Treatment, Named Breakthrough Therapy in China

Legend Biotech and Janssen’s investigational CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel) has been given breakthrough therapy designation in China as a potential treatment of relapsed or refractory multiple myeloma. Cilta-cel refers to both LCAR-B38M, the name given to the therapy in China, and JNJ-4528, the…

FDA Approves Darzalex Triple Combo for Advanced Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab), in combination with Kyprolis (carfilzomib) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma after one to three lines of therapy. Specifically, Darzalex — created by Genmab, and developed and commercialized by Janssen Pharmaceuticals — was approved…

Ide-cel Application Resubmitted to FDA With Requested Data

Bristol Myers Squibb and Bluebird Bio have resubmitted a biologics license application (BLA) with additional information requested by the U.S. Food and Drug Administration to consider the approval of idecabtagene vicleucel (ide-cel) for adults with hard-to-treat multiple myeloma. According to a press release, the BLA now includes further details on the…