Tisagenlecleucel

Tisagenlecleucel
Clinical data
Pronunciationtis" a jen" lek loo' se
/ˌtɪsədʒen'leklusel/
Trade namesKymriah
Other namesCTL019, CART-19
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa617053
License data
Pregnancy
category
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life16.8 days
Identifiers
CAS Number
DrugBank
UNII
KEGG

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).[10][7]

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.[10]

  1. ^ "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.
  2. ^ "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.
  3. ^ "KYMRIAH (Novartis Pharmaceuticals Australia Pty LTD) | Therapeutic Goods Administration (TGA)". Archived from the original on 2 January 2024. Retrieved 2 January 2024.
  4. ^ "KYMRIAH (Novartis Pharmaceuticals Australia Pty LTD) | Therapeutic Goods Administration (TGA)". Archived from the original on 2 January 2024. Retrieved 2 January 2024.
  5. ^ "KYMRIAH (Novartis Pharmaceuticals Australia Pty LTD) | Therapeutic Goods Administration (TGA)". Archived from the original on 2 January 2024. Retrieved 2 January 2024.
  6. ^ "Summary Basis of Decision (SBD) for Kymriah". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
  7. ^ a b "Kymriah- tisagenlecleucel injection, suspension". DailyMed. 14 June 2019. Archived from the original on 22 October 2020. Retrieved 1 April 2020.
  8. ^ "Kymriah (tisagenlecleucel)". U.S. Food and Drug Administration. 7 July 2022. Archived from the original on 19 November 2022. Retrieved 19 November 2022.
  9. ^ Cite error: The named reference Kymriah EPAR was invoked but never defined (see the help page).
  10. ^ a b "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.
  11. ^ "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.