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Tisagenlecleucel 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...
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 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 Novartis Kymriah CAR-T Cell Therapy for Adult Patients with Relapsed or Refractory Follicular Lymphoma
68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile1 Sustained clinical benefit from...
Kymriah (tisagenlecleucel) Receives Second FDA Approval to Treat Appropriate Patients with Large B-Cell Lymphoma
Basel, May 1, 2018 - Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication - the ...
FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia
August 30, 2017 – The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of...
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Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma