Difference between revisions of "Tebentafusp (Kimmtrak)"

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Bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100-positive cells.
 
Bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100-positive cells.
  
==Preliminary data==
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==Diseases for which it is used==
===[[Uveal melanoma]]===
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*[[Uveal melanoma]]
# '''IMCgp100-202:''' Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. [https://doi.org/10.1056/nejmoa2103485 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392
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==History of changes in FDA indication==
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*2022-01-25: Approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic [[uveal melanoma]]. ''(Based on IMCgp100-202)''
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==History of changes in EMA indication==
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*2022-04-01: Initial authorization as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic [[uveal melanoma]].
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==Also known as==
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*'''Code name:''' IMC-gp100
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*'''Generic name:''' tebentafusp-tebn
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*'''Brand name:''' Kimmtrak
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[[Category:Drugs]]
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[[Category:Intravenous medications]]
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[[Category:Uveal melanoma medications]]
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[[Category:Immunotherapeutic]]
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[[Category:EMA approved in 2022]]
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[[Category:FDA approved in 2022]]

Latest revision as of 00:43, 29 July 2023

Mechanism of action

Bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100-positive cells.

Diseases for which it is used

History of changes in FDA indication

  • 2022-01-25: Approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. (Based on IMCgp100-202)

History of changes in EMA indication

  • 2022-04-01: Initial authorization as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Also known as

  • Code name: IMC-gp100
  • Generic name: tebentafusp-tebn
  • Brand name: Kimmtrak