17 March 2016 - Study data subsequently submitted allow quantification / still major added benefit for women.

Dabrafenib (Tafinlar) has been approved since 2013 for the treatment of adults with advanced, i.e. metastatic or unresectable, melanoma with a BRAF V600 mutation. Since September 2015, dabrafenib has been approved for this therapeutic indication also in combination with trametinib (Mekinist). In the end of 2015, the German Institute for Quality and Efficiency in Health Care (IQWiG) determined in two dossier assessments: There is an indication of a major added benefit for women and of a non-quantifiable added benefit for men for this combination therapy.

To quantify this added benefit also for men, the drug manufacturer subsequently submitted study data in the commenting procedure, which the Institute investigated in an addendum. According to the findings, there is now an indication of a considerable added benefit for men. For women, there is still an indication of a larger, i.e. major added benefit.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/dabrafenib/trametinib-considerable-added-benefit-for-men-with-advanced-melanoma.7214.html