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Roche, Daiichi gets US clearance to treat advanced Melanoma

Roche Holding AG and Daiichi Sankyo win US approval to sell drug for treating advanced Melanoma, a form of skin cancer
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Roche Holding AG and Daiichi Sankyo Co have secured U.S. approval to sell a pill for treating deadliest form of skin cancer melanoma, Bloomberg reported.

The Food and Drug Administration approved Zelboraf as a therapy for patients whose tumours have spread or can’t be removed surgically, the reports said.

The drug Zelboraf may assist patients suffering from advanced melanoma. The drug from Roche of  Basel, Switzerland and Tokyo-based Daiichi will compete with Bristol-Myers Squibb Co’s Yervoy cleared as the first treatment proven to extend lives of advanced melanoma patients.

“This has been an important year for patients with late- stage melanoma,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said. “Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” he added.

The sales of Zelboraf may reach 700 million Swiss francs by 2015, Jack Scannelll,an analyst with Sanford C Bernstein & Co in London said.  The Food and Drug Administration in clearing the drug also approved a companion test to help determine if a melanoma patient has the mutation.

 “The FDA approval of Zelboraf marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options,” said Hal Barron, chief medical officer and head of  Global Product Development at Roche’s Genentech unit.

Melanoma is a malignant tumor of melanocytes. Melanocytes are cells that produce the dark pigment, melanin, which is responsible for the color of skin. They predominantly occur in skin, but are also found in other parts of the body.

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