Novartis sales and marketing update

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) reversed a previous decision and found that Tafinlar dabrafenib plus Mekinist trametinib provided “considerable added benefit” compared to Zelboraf vemurafenib for men with metastatic or unresectable melanoma with a BRAF V600 mutation. In December, IQWiG found a “non-quantifiable added benefit” for the combination in men. Novartis subsequently submitted subgroup data from the Phase III COMBI-v (MEK116513) trial of Tafinlar plus Mekinist. IQWiG said the subgroup data “showed no proof of an effect modification by sex for the following outcomes: symptoms, health-related quality of life, health status, severe and serious adverse events and discontinuations due to such events.” IQWiG confirmed its earlier assessment that Tafinlar plus Mekinist had a “major added benefit” vs. Zelboraf for women in the indication (see BioCentury, Jan. 25). ...