FDA approves new drug for late-stage melanoma

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The U.S. Food and Drug Administration has approved the first  melanoma  drug in 13 years. The new drug, ipilimumab, which will be sold under the brand name Yervoy and manufactured by Bristol-Myers Squibb, is designed to stop the cancer cells from growing by stimulating the immune system to recognize the cancer cells as something to attack.

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” Richard Pazdur, M.D., director of the FDA’s Office of Oncology Drug Products said in a press statement.”Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”

“It’s good solid base hit, but it’s not a home run,” says Tim Turnham, executive director of the Melanoma Research Foundation. “The response rates are in the low 20% rate, so three-fourths of the people who take it won’t benefit from it,” Turnham says. “It’s pretty clear we still have a long way to go.”

The drug extended survival for advanced (stage 4) metastatic melanoma patients beyond standard of care by about 4 months in patients who had already failed another form of therapy. While it’s currently being used only in stage 4 melanoma patients, Turnham says there is interest in using it in some stage 3 patients as well.

Turnham adds that another drug is expected out this year and that if you could combine them with the first killing the tumor cells and the other stimulating the immune system, “That’s exciting to think about.

“most people believe the answers will only be found in combinations of drugs, two or more together,” he says.

Melanoma is the most serious type of skin cancer. If the cancer is found early, it can be easily removed and treated.  But if the cancer cells grow and spread, it can be very difficult to control, according to the National Institutes of Health. An estimated 114,900 new cases of melanoma were diagnosed in the U.S. in 2010, according to the Skin Cancer Foundation, with nearly 8,700 resulting in death.

While  the real cause of melanoma is still unknown, experts says about 65% of cases can be attributed to ultraviolet  radiation from the sun.  It’s the most common form of cancer for 25-29 years old and the second most common for 15-29 years old.

The side effects of ipilimumab seem to be fairly rare and can be easily managed, says Dr. Douglas W. Blayney from the American Society of Clinical Oncology. But he cautions that as the treatment is more widely used, there could be rare, unusual infections.

According to a study published in the New England Journal of Medicine in 2010, patients who received ipilimumab lived on average 32% longer and had a 20% greater chance of surviving one year, compared with patients who received a melanoma vaccine instead.  Another positive Blayney adds, is, “Most people who have found success with it can tolerate long-term treament with it.”

But the big hiccup according to Blayney may be the price. “It’s likely to be expensive,” he says.

Turnham makes a broader point. “Not only does this drug offer new hope for patients, but the approval of this drug highlights the importance for patients to be aware of their treatment options, because the landscape for melanoma is changing quickly. Patients who are aware of the new treatments coming out in their field have the best chance of surviving. It’s just another example of how cancer patients need to take better control of their cancer care.”

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Filed under: Cancer • Skin Cancer

Categories : FDA

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