GSK Withdraws Application For Mekinist-Tafinlar In Europe

GlaxoSmithKline announced that it has withdrawn the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of Mekinist (trametinib) in combination with the previously approved BRAF inhibitor Tafinlar (dabrafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

GSK said it will re-submit the application for the combined therapy once additional data from an ongoing Phase III program become available. “The Committee for Medicinal Products for Human Use (CHMP) of the EMA has indicated that the data provided to date by GSK did not allow the Committee to conclude on a positive benefit-risk balance of the combination,” the company said in its press release.

The initial application for Mekinist-Tafinlar was based on data from an open-label randomized three-arm phase II study submitted by GSK to the EMA in 2012. The trial assessed the safety and efficacy of dabrafenib 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 COMBI-d study were also provided to the EMA earlier in 2014.

Dr Rafael Amado, Head of Oncology R&D at GSK, said, “Although we have withdrawn our application, we remain committed to providing further data from our ongoing Phase III development program to support a subsequent re-submission in Europe. 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.”

A separate application for Mekinist as a single agent in adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, filed simultaneously with the application for the Mekinist-Tafinlar combination therapy, is still under review by the EMA.