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