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Breyanzi News
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...
Monthly News Roundup - May 2024
FDA Clears GSK’s Benlysta Autoinjector for Systemic Lupus Erythematosus (SLE) in Children In May, the U.S Food and Drug Administration (FDA) cleared GSK’s Benlysta subcutaneous autoinjector (given as ...
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 ...
Monthly News Roundup - May 2024
FDA Clears GSK’s Benlysta Autoinjector for Systemic Lupus Erythematosus (SLE) in Children In May, the U.S Food and Drug Administration (FDA) cleared GSK’s Benlysta subcutaneous autoinjector (given as ...
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...
FDA Approves First CAR T-Cell Therapy for Adults With Leukemia or Lymphoma, Breyanzi
MONDAY, March 18, 2024 – The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel [liso-cel]) as the first CD19-directed chimeric antigen receptor (CAR) T-cell therapy...
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: 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...
Liso-Cel Cost-Effective for Second-Line Relapsed/Refractory Lymphoma
THURSDAY, Jan. 4, 2024 – Lisocabtagene maraleucel (liso-cel), a chimeric antigen receptor (CAR) T-cell therapy, is cost-effective for second-line diffuse large B-cell lymphoma (DLBCL) therapy,...
CAR-T Therapies Not Cost-Effective for Diffuse Large B-Cell Lymphoma
MONDAY, Dec. 4, 2023 – For patients with diffuse large B-cell lymphoma (DLBCL), the chimeric antigen receptor T-cell therapies (CAR-T) axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel...
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...
Further information
Related condition support groups
Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma