Is Tebentafusp approved by the FDA?

Tebentafusp received FDA approval on January 25, 2022. It is a prescription medication used to treat adults with uveal melanoma, a type of cancer in the eye that cannot be removed by surgery or has metastasized.

How Tebentafusp Works

Tebentafusp works by targeting a specific protein on the surface of cancer cells and activating the immune system to attack these cells. It is administered intravenously, typically once a week, with the initial doses requiring extended observation due to potential severe side effects.

Usage and Dosage

Tebentafusp is given as an intravenous solution, with the initial doses carefully monitored:

Day 1: 20 mcg IV
Day 8: 30 mcg IV
Day 15: 68 mcg IV
Thereafter: 68 mcg IV weekly

Patients must be confirmed as HLA-A*02:01 positive before starting treatment.

Side Effects

Common side effects of Tebentafusp include:

Fever, chills
Trouble breathing
Confusion
Severe vomiting or diarrhea
Fast or irregular heartbeats
Tiredness
Nausea, stomach pain
Rash, itching, dry skin
Headache
Swelling
Abnormal liver function tests

Severe side effects such as cytokine release syndrome (CRS) may occur, characterized by fever, chills, trouble breathing, and severe gastrointestinal symptoms. Immediate medical attention is necessary if these symptoms develop.

Warnings and Precautions

Patients should inform their healthcare provider if they have a history of liver problems or are pregnant. Tebentafusp may harm an unborn baby, so effective contraception is recommended during treatment and for at least one week after the last dose. Breastfeeding is also not advised during this period.

Conclusion

Tebentafusp (Kimmtrak) is FDA approved for the treatment of uveal melanoma as of January 25, 2022. While it offers a new treatment option for this rare cancer, patients should be aware of the potential side effects and the necessity for regular monitoring during therapy.

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