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

 
• By Emily Hayes

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.

Publication of early but impressive data for GlaxoSmithKline PLC’s combination of dabrafenib and trametinib for metastatic melanoma could justify off-label use if FDA approves the drugs as single agents, a development that could damage Roche/Genentech Inc.’s BRAF inhibitor Zelboraf.

Dabrafenib, a BRAF inhibitor, and trametinib, a first-in-class MEK inhibitor, are both pending approval as monotherapies with FDA, following presentation...

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