Tebentafusp

Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer).[3][4][6]

Tebentafusp
Clinical data
Trade namesKimmtrak
Other namesIMCgp100, tebentafusp-tebn
License data
Pregnancy
category
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

The most common side effects include cytokine release syndrome, rash, pyrexia (fever), pruritus (itching), fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting.[3][4]

Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.[3][4] It was approved for medical use in the United States in January 2022.[3][4]

Medical uses

Tebentafusp is indicated for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.[3][4][6]

History

Efficacy was evaluated in IMCgp100-202 (NCT03070392), a randomized, open-label, multicenter trial of 378 participants with metastatic uveal melanoma.[4] Participants were required to be HLA-A*02:01 genotype positive identified by a central assay.[4] Participants were excluded if prior systemic therapy or localized liver-directed therapy were administered.[4] Prior surgical resection of oligometastatic disease was permitted.[4] Participants with clinically significant cardiac disease or symptomatic, untreated brain metastases were excluded.[4]

The U.S. Food and Drug Administration (FDA) granted Immunocore's application for tebentafusp priority review, breakthrough therapy, and orphan drug designations.[4]

Society and culture

On 24 February 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kimmtrak, intended for the treatment of uveal melanoma.[7][8] The applicant for this medicinal product is Immunocore Ireland Limited.[7][8] Tebentafusp was approved for medical use in the European Union in April 2022.[5]

References
  1. "Kimmtrak". Therapeutic Goods Administration (TGA). 15 June 2022. Archived from the original on 18 June 2022. Retrieved 18 June 2022.
  2. "Kimmtrak Product information". Health Canada. 25 April 2012. Retrieved 30 September 2022.
  3. "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022.
  4. "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. This article incorporates text from this source, which is in the public domain.
  5. "Kimmtrak EPAR". European Medicines Agency (EMA). 24 January 2022. Archived from the original on 22 April 2022. Retrieved 22 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. 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.
  7. "Kimmtrak: Pending EC decision". European Medicines Agency. 24 February 2022. Archived from the original on 26 February 2022. Retrieved 27 February 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. "New medicine for rare type of eye cancer". European Medicines Agency (EMA) (Press release). 25 February 2022. Archived from the original on 27 February 2022. Retrieved 27 February 2022.
  • "Tebentafusp". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03070392 for "Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma" at ClinicalTrials.gov


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