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GlaxoSmithKline withdraws EMA filing for Mekinist/Tafinlar combination in melanoma

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GlaxoSmithKline recently announced that it has withdrawn its Marketing Authorization Application to the European Medicines Agency for the use of trametinib combined with dabrafenib for treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations.

The application for the use of trametinib (Mekinist) as a single agent in the same patient population, submitted simultaneously with the authorization application for the combination, is still being reviewed by the EMA.

According to GlaxoSmithKline, the Committee for Medicinal Products for Human Use of the EMA has indicated that the data provided to date by the company did not allow the Committee to conclude on a positive benefit-risk balance of the combination.

The regulatory submission for the combination was based on the results from an open-label randomized three-arm phase 2 study, provided to EMA in 2012. The study intended to examine the safety and efficacy of dabrafenib (Tafinlar) in combination with two different doses of trametinib compared to dabrafenib monotherapy in patients with unresectable or metastatic BRAF V600 E or K mutation-positive melanoma.

Additional data from the randomized, double-blind phase 3 study (COMBI-d) comparing the combination of dabrafenib and trametinib to dabrafenib and placebo as first-line therapy in the same patient population were also provided to EMA earlier this year.

GlaxoSmithKline intends to resubmit the authorization application for the combined use of dabrafenib and trametinib when additional data from the ongoing phase 3 program become available.

“Although we have withdrawn our application, we remain committed to providing further data from our ongoing phase 3 development program to support a subsequent re-submission in Europe,” Rafael Amado, MD, head of oncology research and development at GlaxoSmithKline, said in a press release. “While significant progress has been made in treating metastatic melanoma over the last few years, we believe more treatment options are needed, and we will work with the European regulators towards making the combination available for patients.”