March 26, 2011

USA: FDA clears first melanoma drug to extend life

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WASHINGTON / The Seattle Times / Health / March 26, 2011

The Food and Drug Administration has approved a breakthrough cancer medication from Bristol-Myers Squibb Co. that researchers have heralded as the first drug shown to prolong the lives of patients with advanced skin cancer.


By MATTHEW PERRONE
AP Health Writer

WASHINGTON — The Food and Drug Administration has approved a breakthrough cancer medication from Bristol-Myers Squibb Co. that researchers have heralded as the first drug shown to prolong the lives of patients with advanced skin cancer.

FDA has approved a medication from Bristol-Myers Squibb. It's heralded as the first to prolong the lives of melanoma patients. Picture: Mel Evans Source: AP

The federal health agency approved the injectable drug, called Yervoy, for late-stage or metastatic melanoma. Melanoma is the deadliest type of skin cancer, but the FDA has only approved two other drugs for advanced melanoma. The newest of those drugs was cleared more than 13 years ago. Neither drug has been shown to significantly extend patient lives.

Known chemically as ipilimumab, the biotech drug only worked in a small segment of patients studied, and on average they lived just four months longer than patients given older medications. But experts say the drug is an important milestone in treating melanoma, which is often unresponsive to therapy.

"Clearly this is not a home run, but it's a solid base hit," said Tim Turnham, director of the Melanoma Research Foundation. "And because we see other things in the pipeline, we think this the first in a series of important new therapies for melanoma."

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AP Health Writer Marley Seaman contributed to this story from New York

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