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

Executive Summary

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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At a time when $10,000-per-month pricing is the norm in oncology, GSK has priced its just-approved BRAF inhibitor Tafinlar at $7,600, on the lower end by today’s standards. Company says it is planning to file the combination of Tafinlar with Mekinist – also just approved by FDA – in a matter of weeks in the U.S.

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