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Kimmtrak FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 31, 2022.

FDA Approved: Yes (First approved January 25, 2022)
Brand name: Kimmtrak
Generic name: tebentafusp-tebn
Dosage form: Injection
Company: Immunocore
Treatment for: Uveal Melanoma

Kimmtrak (tebentafusp-tebn) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

  • Uveal (intraocular) melanoma is a rare type rare and aggressive form of melanoma which affects the uveal tract of the eye. 
  • Kimmtrak works by specifically targeting gp100, a lineage antigen expressed in melanocytes and melanoma.
  • Kimmtrak is administered via intravenous infusion over 15-20 minutes once every week.
  • The Kimmtrak product label carries a boxed warning for cytokine release syndrome. Serious adverse reactions include skin reactions and elevated liver enzymes.
  • Common adverse reactions include cytokine release syndrome, rash, pyrexia, pruritus, laboratory abnormalities, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting.

Development timeline for Kimmtrak

Jan 26, 2022Approval FDA Approves Kimmtrak (tebentafusp-tebn) for the Treatment of Unresectable or Metastatic Uveal Melanoma
Apr  4, 2019Immunocore‚Äôs Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma

Further information

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