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Ciltacabtagene Autoleucel News
FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T Cell Immunotherapies
June 27, 2025 – The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed...
Cilta-Cel Treatment Safe, Effective for Relapsed/Refractory Multiple Myeloma
TUESDAY, Oct. 8, 2024 – Ciltacabtagene autoleucel (cilta-cel) CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM) results in a deep and durable response, according to a study...
FDA Medwatch Alert: Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System
June 26, 2024 – Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System A...
FDA Medwatch Alert: FDA Requires Boxed Warning for T Cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous CAR T Cell Immunotherapies
April 18, 2024 – In November 2023, the Food and Drug Administration (FDA) posted a safety communication to provide information about reports of T cell malignancies including chimeric antigen...
FDA Approves Carvykti for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
HORSHAM, PA (April 5, 2024) – Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the tr...
FDA Medwatch Alert: FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
November 28, 2023 – The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment...
FDA Approves Carvykti (ciltacabtagene autoleucel) BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., February 28, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved Carvykti (ciltacabtagene a...