FDAnews Drug Daily Bulletin

FDA Approves GSK’s Combination Therapy for Unresectable or Metastatic Melanoma

Jan. 10, 2014

The FDA has approved GlaxoSmithKline’s Mekinist and Tafinlar combination therapy for patients with unresectable or metastatic melanoma who have BRAF V600E or V600K mutations, contingent upon the results of an ongoing Phase III trial, the British drugmaker said Thursday.

The decision was based on results of a Phase I/II trial that showed that patients treated with the combination therapy had a 76 percent durable response rate over 10.5 months, as compared to a 54 percent response rate over 5.6 months in patients given monotherapy.

The Phase III trial, currently in progress, is a postmarketing requirement to confirm the clinical benefit of Mekinist (trametinib) and Tafinlar (debrafenib), said GSK spokesperson Anna Padula. The study is evaluating the combination therapy against single-agent debrafenib with progression-free survival as its primary endpoint.

Mekinist and Tafinlar were given priority review in September and approved via the agency’s accelerated approval pathway. — Lena Freund

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