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Kymriah 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...
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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Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Acute Lymphoblastic Leukemia