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Janssen Initiates Rolling FDA Submission for CAR T-cell Therapy for Refractory Multiple Myeloma

NEW YORK – Janssen Pharmaceutical on Monday said it has begun a rolling submission of its biologics license application for the multiple myeloma CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel) with the US Food and Drug Administration.

The drugmaker is seeking FDA approval for the dual-binding BCMA autologous CAR T-cell therapy as a treatment for relapsed or refractory multiple myeloma. The FDA has granted breakthrough therapy status to cilta-cel in this setting. Janssen collaborated with Legend Biotech to develop cilta-cel, and this filing marks the first regulatory application for Janssen for a cell-based treatment.

At the American Society of Hematology's annual meeting earlier this month, Janssen presented results from the Phase Ib/II CARTITUDE-1 study, in which out of 97 refractory multiple myeloma patients receiving cilta-cel, 97 percent saw their tumors shrink and 67 percent experienced a complete response. At data cutoff, 72 percent of patients were still responding to treatment.