Ipilimumab Approved for Melanoma
Article date: March 25, 2011
By Eleni Berger
The US Food and Drug Administration (FDA) has approved the drug ipilimumab for advanced melanoma, the most serious form of skin cancer.
Sold as Yervoy, ipilimumab can now be used to treat melanoma that can't be removed by surgery or that has spread (metastasized) to distant parts of the body, the agency announced Friday.
Patients Lived Longer
The move comes after a recent clinical trial showed the drug helped patients live longer. Those in the study who got ipilimumab lived about 10 months, while those who received a different experimental treatment lived about 6.5 months.
The people who took part in the study had melanoma that had spread and could not be surgically removed, and their cancer had stopped responding to other treatments.
Ipilimumab is now also being tested in patients with metastatic melanoma that has not yet been treated, according to manufacturer Bristol-Myers Squibb.
Potentially Serious Side Effects
Ipilimumab works by helping the body’s immune system recognize and attack melanoma cells. About 13% of patients had a serious immune reaction to the drug; some patients died from this reaction. Because of this, the manufacturer will be required to inform doctors about the risks and to issue special medication guides to inform patients of the potential side effects.
More common side effects of ipilimumab include diarrhea, skin rash, and fatigue. Less common but potentially more serious side effects include liver failure, hormone problems, severe skin reactions, and inflammation of the intestines (colitis).
Few Treatment Options for Advanced Melanoma
Despite the potential risks, the approval of ipilimumab is welcome news for patients who have had few treatment options until now. Chemotherapy can shrink some advanced melanomas, but the tumors often begin growing again soon afterward. The immune-boosting proteins interferon and interleukin-2 have also been shown to be helpful for a small group of patients, but can have severe side effects.
“Ipilimumab is the first drug ever to be shown to produce an improvement in overall survival for patients with metastatic melanoma,” says Jedd Wolchok, MD, PhD, a medical oncologist at Memorial Sloan-Kettering Cancer Center who has conducted some of the studies of the drug. “This is a significant achievement in a disease which has been so resistant to standard therapies.”
Warning Signs of Melanoma
Melanoma is a less common form of skin cancer – only about 5% of skin cancers are melanomas – but it is one of the deadliest. Only about 15%-20% of people with advanced melanoma live 5 years beyond their diagnosis.
But when detected at an early stage, melanoma is very treatable, which is why it is important to know the possible warning signs. Watch for any moles or spots on your skin that are growing, large, irregularly shaped, or not uniform in color. Have a doctor check these spots, along with any sore that doesn’t heal or any mole that begins bleeding, oozing or has other changes. Learn more about melanoma in our Detailed Guide.
It’s also important to protect your skin, especially if you’ve had skin cancer before. Sun exposure is a major risk factor for melanoma and other forms of skin cancer. Cover up with clothing and a hat, use sunscreen, and seek shade, especially between 10am and 4pm, when the sun's ultraviolet rays tend to be strongest.
Reviewed by members of the ACS Medical Content and News Staff
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