Yervoy Gets Expanded Approval for Earlier-Stage Melanoma

The United States Food and Drug Administration (FDA) has expanded the approval indication for Yervoy (ipilimumab) to include treatment of stage III melanoma.

Melanoma is the most deadly form of skin cancer, as it is more likely than other forms of skin cancer to spread from its site of origin to other sites in the body. It often begins in the form of a mole, and tends to spread to sites such as nearby lymph nodes, liver, lungs, and the brain. The National Cancer Institute estimates that over 73,000 new diagnoses of melanoma will occur this year.

Stage III melanoma refers to melanoma that has spread to one or more lymph nodes. Despite initial treatment that appears to eliminate all detectable cancer, patients with stage III melanoma remain at high risk for developing a cancer recurrence.

The expanded approval of Yervoy includes its use for the treatment of stage III melanoma following surgery, to reduce the risk of a cancer recurrence. Yervoy was already approved in 2011 for the treatment of advanced stages of melanoma, for which surgery is not an option.

Yervoy is a monoclonal antibody that helps the immune system to fight cancer. Yervoy blocks the molecule, CTLA-4 (cytotoxic T-lymphocyte antigen). The CTLA-4 is believed to play a role in reducing the immune system’s ability to fight cancer. Through blocking the effects of CTLA-4 with Yervoy, the immune system’s ability to fight cancer is restored.

The clinical trial that led to the expanded approval of Yervoy included 951 patients with stage III melanoma who were treated with Yervoy or a placebo (inactive substitute) after the surgical removal of their cancer.

  • At 26 months, only 49% of patients who were treated with Yervoy experienced a recurrence of their cancer, compared with 62% of patients who received placebo.
  • Data for overall survival has not yet occurred, but will be evaluated once data are mature.

Richard Pazdur MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research stated that “This new use of the drug in earlier stages of the disease builds on our understanding of the immune system’s interaction with cancer.”

Reference: United States Food and Drug Administration. FDA News Release. FDA approves Yervoy to reduce the risk of melanoma returning after surgery. Available at: Accessed October 29, 2015.

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