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Tebentafusp information


Tebentafusp
Clinical data
Trade namesKimmtrak
Other namesIMCgp100, tebentafusp-tebn
License data
  • US DailyMed: Tebentafusp
Pregnancy
category
  • AU: C[1]
Routes of
administration
Intravenous
ATC code
  • L01XX75 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)[1]
  • CA: ℞-only / Schedule D[3]
  • UK: POM (Prescription only)[4]
  • US: WARNING[2]Rx-only[5][6]
  • EU: Rx-only[7]
Identifiers
CAS Number
  • 1874157-95-5
DrugBank
  • DB15283
UNII
  • N658GY6L3E
KEGG
  • D12296

Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer).[5][6][8] Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.[5][6] Tebentafusp is given by intravenous infusion.[5]

The most common side effects include cytokine release syndrome, rash, pyrexia (fever), pruritus (itching), fatigue (tiredness), nausea, chills, abdominal pain (stomach pain), edema (swelling), hypotension (low blood pressure), dry skin, headache, and vomiting, and abnormal liver blood tests.[5][6][9]

Tebentafusp was approved for medical use in the United States in January 2022.[5][6][9] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10][11]

  1. ^ a b "Kimmtrak APMDS". Therapeutic Goods Administration (TGA). 15 June 2022. Archived from the original on 18 June 2022. Retrieved 18 June 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. ^ "Kimmtrak Product information". Health Canada. 25 April 2012. Archived from the original on 1 October 2022. Retrieved 30 September 2022.
  4. ^ "Kimmtrak (tebentafusp) 200 micrograms/ mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 4 July 2022. Archived from the original on 10 March 2024. Retrieved 17 June 2023.
  5. ^ a b c d e f "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022.
  6. ^ a b c d e "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ Cite error: The named reference Kimmtrak EPAR was invoked but never defined (see the help page).
  8. ^ Damato BE, Dukes J, Goodall H, Carvajal RD (July 2019). "Tebentafusp: T Cell Redirection for the Treatment of Metastatic Uveal Melanoma". Cancers. 11 (7): 971. doi:10.3390/cancers11070971. PMC 6679206. PMID 31336704.
  9. ^ a b "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Archived from the original on 21 January 2023. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  11. ^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. Public Domain This article incorporates text from this source, which is in the public domain.

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