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Newly Approved Drug for Metastatic Melanoma Nearly Doubles Median Survival

Newly Approved Drug for Metastatic Melanoma Nearly Doubles Median Survival

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Zelboraf changes the natural history of this disease

 
Researchers from UCLA’s Jonsson Comprehensive Cancer Center, together with scientists from 12 other sites in the United States and Australia, report for the first time that a newly approved drug for patients with metastatic melanoma nearly doubles median survival times, a finding that will change the way this deadly form of skin cancer is treated.

The data comes from an international Phase II study of Zelboraf that included 132 patients followed for at least one year.
Patients with this advanced form of melanoma that has spread to other organs typically survive about nine months. Patients taking Zelboraf, which blocks a mutated BRAF protein, survived an average of 15.9 months, said study senior author Dr. Antoni Ribas, a professor of hematology/oncology and a researcher at UCLA’s Jonsson Cancer Center.

“This study shows that Zelboraf changes the natural history of this disease,” Ribas said. “This data is beyond what I would have expected. We’re seeing a significant number of patients with durable responses to the drug, and that the whole group of treated patients is living longer. These results tell us that this drug is having a very big impact, and this changes the way we treat metastatic melanoma.”

The study appears Feb. 23, 2012 in the peer-reviewed New England Journal of Medicine.

About 50 percent of patients with metastatic melanoma, or 4,000 people a year, have the BRAF mutation and can be treated with Zelboraf, a pill taken twice a day, Ribas said. Of those, 53 percent have an objective response to the drug, meaning their tumors shrink by more than 30 percent. An additional 30 percent of patients have tumor responses of lesser magnitude. Only 14 percent of patients with the BRAF mutation failed to respond to Zelboraf.

The drug represents a breakthrough in treating metastatic melanoma. Prior to this, 10 percent or less of patients with this advanced form of the disease responded to any of the available conventional treatments, Ribas said.

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