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Speedy Approval Of Roche's Zelboraf Puts Pressure On Bristol's Yervoy

This article was originally published in The Pink Sheet Daily

Executive Summary

Personalized melanoma medicine vemurafenib set to sell for $9,400 a month, says Genentech. Genetic testing should be available right away.

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FDA’s Oncologic Drugs Advisory Committee will review the drug/device combination for treatment of patients with unresectable ocular melanoma that is metastatic to the liver. The system, which uses the chemotherapy drug melphalan, has shown significant improvement in hepatic progression-free survival.

Glaxo’s Emerging BRAF/MEK Melanoma Combo Threatens Roche’s Zelboraf

Phase I/II data for Glaxo’s BRAF/MEK combination of dabrafenib and trametinib, both pending FDA approval as single agents, suggest compelling efficacy. The combination may see off-label use if the drugs are approved as monotherapies, though payment could be a big hurdle.

Glaxo’s Emerging BRAF/MEK Melanoma Combo Threatens Roche’s Zelboraf

Phase I/II data for Glaxo’s BRAF/MEK combination of dabrafenib and trametinib, both pending FDA approval as single agents, suggest compelling efficacy. The combination may see off-label use if the drugs are approved as monotherapies, though payment could be a big hurdle.

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