Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body's own T cells to fight cancer (adoptive cell transfer).[9][7]
Serious side effects occur in most patients.[10] The most common serious side effects are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure) and decreases in platelets (components that help the blood to clot), hemoglobin (the protein found in red blood cells that carries oxygen around the body) or white blood cells including neutrophils and lymphocytes.[10] Serious infections occur in around three in ten diffuse large B-cell lymphoma (DLBCL) patients.[10]
T cells from a person with cancer are removed, genetically engineered to make a specific chimeric cell surface receptor with components from both a T-cell receptor and an antibody specific to a protein on the cancer cell, and transferred back to the person. The T cells are engineered to target a protein called CD19 that is common on B cells. A chimeric T cell receptor ("CAR-T") is expressed on the surface of the T cell.[medical citation needed]
It was invented and initially developed at the University of Pennsylvania; Novartis completed development, obtained FDA approval, and markets the treatment.[11] In August 2017, it became the first FDA-approved treatment that included a gene therapy step in the United States.[9]
^"Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
^"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
^"Archived copy". Archived from the original on 2 January 2024. Retrieved 2 January 2024.{{cite web}}: CS1 maint: archived copy as title (link)
^"Archived copy". Archived from the original on 2 January 2024. Retrieved 2 January 2024.{{cite web}}: CS1 maint: archived copy as title (link)
^"Archived copy". Archived from the original on 2 January 2024. Retrieved 2 January 2024.{{cite web}}: CS1 maint: archived copy as title (link)
^"Summary Basis of Decision (SBD) for Kymriah". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
^ ab"Kymriah- tisagenlecleucel injection, suspension". DailyMed. 14 June 2019. Archived from the original on 22 October 2020. Retrieved 1 April 2020.
^"Kymriah (tisagenlecleucel)". U.S. Food and Drug Administration. 7 July 2022. Archived from the original on 19 November 2022. Retrieved 19 November 2022.
^ ab"FDA approval brings first gene therapy to the United States". U.S. Food & Drug Administration (FDA) (Press release). Archived from the original on 24 April 2019. Retrieved 31 August 2017.
^ abcCite error: The named reference Kymriah EPAR was invoked but never defined (see the help page).
^"BLA 125646 Tisagenlecleucel - Novartis Briefing document to FDA ODAC" (PDF). Food and Drug Administration. Archived (PDF) from the original on 16 July 2017. Retrieved 16 July 2017.
Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses...
to the FDA's first two approvals of CAR T cells in 2017, those for tisagenlecleucel (Kymriah), marketed by Novartis originally for B-cell precursor acute...
medications, such as the CD20 antibody rituximab and the CD19 CAR T cell tisagenlecleucel. The experimental drug TGN1412—also known as Theralizumab—caused extremely...
of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel". Journal of Hematology & Oncology. 11 (1): 35. doi:10.1186/s13045-018-0571-y...
treatment for melanoma in patients who have recurring skin lesions Tisagenlecleucel (Kymriah): treatment for B cell lymphoblastic leukemia Valoctocogene...
multiple previous immunotherapies. The first 2 adoptive T-cell therapies, tisagenlecleucel and axicabtagene ciloleucel, were approved by the FDA in 2017. Another...
Memorial Sloan Kettering Cancer Center. Retrieved October 15, 2019. "Tisagenlecleucel (Kymriah) Approved to Treat Some Lymphomas". National Cancer Institute...
cell disease. In August, the FDA approved tisagenlecleucel for acute lymphoblastic leukemia. Tisagenlecleucel is an adoptive cell transfer therapy for...
can initiate a cytotoxic response.[medical citation needed] In 2017, tisagenlecleucel was approved by the FDA as a CAR-T therapy for people with acute B-cell...
expensive. Cost of single infusions of axicabtagene ciloleucel: US$373,000 Tisagenlecleucel: US$475,000 T cell Efficacy of treatment highly depends on whether...
lymphoma with two failed systemic treatments), axicabtagene ciloleucel, tisagenlecleucel (for large B-cell lymphoma), and brexucabtagene autoleucel(for mantle...
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