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Over A Decade In The Making, MEK Inhibitors Break Through In Melanoma

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

As if moving on from failures of the past, MEK inhibitors are now being positioned as part of the next standard of care in BRAF-mutant melanoma. Glaxo prepares to file trametinib as a monotherapy in 2012, after reporting striking Phase III results, while Novartis/Array’s MEK 162 demonstrates value in area of unmet need.

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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.

Tandem Approval Brings GSK’s Tafinlar And Mekinist To A Market Ready To Test Combinations

Glaxo’s BRAF inhibitor dabrafenib and MEK inhibitor trametinib were approved as single agents for advanced melanoma, but the real promise lies in combination therapy for better efficacy and safety. Labeling for trametinib notes it is not indicated in patients who have already received BRAF therapy.

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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