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On May 26, 2022, the European Commission (EC) granted a conditional marketing authorization to ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed/refractory multiple myeloma (MM).1 This decision is made 2 months after the favorable opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Cilta-cel’s approval is based on the results of the CARTITUDE-1 trial and depends on the provision of comprehensive and long-term data at a later stage. The current indication is for treating adult patients with relapsed/refractory MM who have received ≥3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.1
Updated data from both the CARTITUDE-1 and CARTITUDE-2 trials are expected to be presented at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA)2022 Hybrid Congress.2,3
Review here the ongoing and planned clinical trials investigating cilta-cel for the treatment of patients with MM.
Management of short-, medium-, and long-term complications in patients receiving CAR T-cell therapy
Complications can arise at any time after the administration of CAR T-cell therapy; however, with these updated guidelines, multidisciplinary teams...
FDA approves ciltacabtagene autoleucel for the treatment of patients with RRMM
On February 28, 2022, it was announced that the U.S. Food and Drug Administration (FDA) granted the approval of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed...
Response to anti-BCMA CAR T therapy in patients with renal dysfunction
Up to half of patients with multiple myeloma (MM) experience renal impairment. While the exact underlying pathology may vary, myeloma cast nephropathy is the most common form of...
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