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Is Keytruda approved for treating unresectable or metastatic melanoma?

high confidence  ·  Last reviewed May 13, 2026

Keytruda (pembrolizumab) is a type of immunotherapy called a PD-1 inhibitor. It works by helping your immune system recognize and attack cancer cells. The FDA has approved Keytruda specifically for patients with unresectable or metastatic melanoma, meaning melanoma that cannot be removed by surgery or has spread to other parts of the body 69.

What the research says

The FDA label for Keytruda clearly states it is indicated for the treatment of patients with unresectable or metastatic melanoma 6. This approval is based on clinical trials showing that Keytruda can shrink tumors and improve survival in these patients. Keytruda belongs to a class of drugs that block the PD-1 pathway, which is a mechanism tumors use to evade the immune system 9. Other PD-1 inhibitors, such as nivolumab, are also approved for the same indication, and sometimes they are used in combination with other drugs like ipilimumab 9. For patients with a specific type of melanoma called uveal melanoma (which starts in the eye), a different drug called tebentafusp may be an option, but Keytruda is not specifically approved for that subtype 10. Overall, Keytruda is a standard first-line treatment option for advanced melanoma 69.

What to ask your doctor

  • Is Keytruda a good treatment option for my type and stage of melanoma?
  • What are the possible side effects of Keytruda, and how are they managed?
  • How is Keytruda given (dose, schedule, and how long will I need treatment)?
  • Are there any other treatments I should consider, such as targeted therapy or clinical trials?
  • How will we know if Keytruda is working for me?

This question is drawn from common patient questions about this topic and answered using cited medical research. We do not provide individualized advice.