FDA approves melanoma drug
The Food and Drug Administration on Friday bolstered the skimpy pharmaceutical arsenal against late-stage melanoma by approving Yervoy, the first drug shown to extend the lives of patients with the deadly skin cancer.
The drug, marketed by Bristol-Myers Squibb Co. of Princeton, N.J., is the first FDA-approved treatment for metastatic melanoma in 13 years and has triggered particular interest among oncologists because there are indications that, in addition to prolonging some patients’ lives, it may cure others.
Melanoma is the most dangerous type of skin cancer, killing an estimated 8,700 people annually in the U.S. About 68,000 new cases were diagnosed in 2010, according to the National Cancer Institute.
Patients with early stages of the disease can usually be treated successfully with surgery.
But existing treatment options for late-stage melanoma, including chemotherapy and Proleukin — the last drug approved for the disease — are effective only in a limited number of patients.
“Late-stage melanoma is devastating, with very few treatment options for patients — none of which previously prolonged a patient’s life,” said Richard Pazdur, head of the FDA’s cancer drug office. “Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”
Patients treated with Yervoy, or with Yervoy and an experimental tumor vaccine, lived 10 months, compared with 6.5 months for patients who received only the vaccine, according to a study cited in the FDA statement.
The extension of life is significant because the study looked at patients who had already received other treatments for late-stage melanoma, said Lynn Schuchter, chief of hematology and oncology at the University of Pennsylvania’s Abramson Cancer Center.
The real promise of Yervoy is that some patients who receive the drug live much longer than 10 months and may be cured, Schuchter said.
Doctors, however, can’t predict which patients will benefit most from the treatment, she said.
Yervoy, known generically as ipilimumab, is a monoclonal antibody — a lab-designed molecule — that blocks a molecule known as cytotoxic T-lymphocyte antigen, or CTLA-4. CTLA-4 is thought to slow or turn off the body’s immune system, compromising its ability to fight off cancerous cells.
“It’s a new mechanism of action, so it may be able to be combined with other treatments,” said Donald Morton, chief of the melanoma program at the John Wayne Cancer Institute in Santa Monica.
Morton said research was underway to see whether Yervoy could be used in combination with surgery to treat melanoma at an earlier stage.
Yervoy is administered intravenously in four treatments over three months and costs $120,000 for the full course, said Bristol-Myers Squibb spokesman Ken Dominski.
The company has financial assistance programs for those who can’t afford the treatment, so “nearly 100% of uninsured patients will have access to the drug,” Dominski said.
Yervoy has serious side effects, including colitis and hepatitis, and can cause severe diarrhea. It is approved with restrictions that require doctors and patients to be informed of the risks and benefits.
