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Yescarta 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...
Second Primary Malignancies Represent Small Proportion of Adverse Events After CAR T-Cell Therapy
WEDNESDAY, March 20, 2024 – Second primary malignancies (SPMs) represent a small proportion of adverse events (AEs) reported by patients receiving chimeric antigen receptor T-cell (CAR T-cell)...
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...
U.S. FDA Approves Label Update for Kite’s Yescarta CAR T-Cell Therapy to Include Overall Survival Data
Yescarta is the First and Only Treatment in Nearly 30 Years to Demonstrate Superior Overall Survival for Patients with Relapsed/Refractory Large B-cell Lymphoma Versus Standard of Care as...
ASH: Axi-Cel CAR T-Cell Treatment Effective in High-Risk Lymphoma Patients
TUESDAY, Dec. 12, 2023 – For patients with relapsed or refractory large B-cell lymphoma, including those with comorbidities, the autologous anti-CD19 chimeric antigen receptor (CAR) T-cell 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...
Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)
SANTA MONICA, Calif.--(BUSINESS WIRE)--Apr. 1, 2022-- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ...
U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta Showing Prophylactic Steroid Use Improves Management of Cytokine Release Syndrome
SANTA MONICA, Calif.--(BUSINESS WIRE)--Jan. 31, 2022-- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved an update to the prescribing...
U.S. FDA Approves Yescarta for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy
SANTA MONICA, Calif.--(BUSINESS WIRE)--Mar. 5, 2021-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yes...
FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma
October 18, 2017 – The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell...
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Diffuse Large B-Cell Lymphoma, Follicular Lymphoma