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Lisocabtagene Maraleucel 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...
Liso-Cel Has Favorable Safety Profile for Outpatients With Large B-Cell Lymphoma
MONDAY, Oct. 7, 2024 – For patients with relapsed/refractory large B-cell lymphoma (LBCL), the autologous, CD19-directed, 4-1BB chimeric antigen receptor T-cell product, lisocabtagene maraleucel...
Outpatient CAR-T Cancer Therapy Can Be Safe, Effective
TUESDAY, Oct. 1, 2024 – Patients with fast-spreading blood cancer respond well to outpatient treatment with CAR-T therapy, the largest study examining its use in a community setting has found. CAR-T...
Toxicities Rare After Two Weeks of CAR T-Cell Therapy Infusion
TUESDAY, July 30, 2024 – New-onset cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are rare beyond two weeks following infusion of CD19-directed...
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...
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma
PRINCETON, N.J.--(BUSINESS WIRE) May 30, 2024 – Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Breyanzi ® (lisocabtagene ...
Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma
PRINCETON, N.J.--(BUSINESS WIRE) May 15, 2024 – Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi ® ...
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...
U.S. FDA Approves Bristol Myers Squibb’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
PRINCETON, N.J.--(BUSINESS WIRE) Mar 14, 2024 – Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi ® ...
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...
U.S. FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with median event-free survival of 10.1 months vs. 2.3 months...
FDA Approves Breyanzi (lisocabtagene maraleucel) CAR-T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma
PRINCETON, N.J.--(BUSINESS WIRE) February 5, 2021 – Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel;...
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Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, B Cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma