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Abecma News
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 Abecma for Relapsed, Refractory Multiple Myeloma
TUESDAY, April 9, 2024 – The U.S. Food and Drug Administration has approved Abecma (idecabtagene vicleucel) as a personalized CAR T-cell therapy for triple-class exposed relapsed or refractory...
U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2024 – Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and...
FDA: CAR T-Cell Therapies May Increase Risk for Rare Secondary Cancers
WEDNESDAY, Jan. 24, 2024 – Citing recent indications that CAR T-cell therapy may cause rare secondary cancers, the U.S. Food and Drug Administration has told pharmaceutical companies to add a boxed...
FDA Warns of Rare Secondary Cancer Risk With CAR-T Therapies
WEDNESDAY, Jan. 24, 2024 (Healthday News) – The U.S. Food and Drug Administration has told drugmakers to add a boxed warning to a type of cancer treatment called CAR-T therapy, saying the treatment...
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...
Racial, Ethnic Differences ID'd for Idecabtagene Vicleucel in Multiple Myeloma
WEDNESDAY, Oct. 25, 2023 – There are some racial and ethnic differences in safety and response to standard of care (SOC) idecabtagene vicleucel (ide-cel) in patients with relapsed/refractory...
FDA Approves Abecma (idecabtagene vicleucel) as the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE) March 26, 2021 – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug...
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