Novartis sales and marketing update

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) said in two dossier assessments that “no added benefit is proven” for Mekinist trametinib monotherapy in patients with metastatic or unresectable melanoma with a BRAF V600 mutation but that Mekinist plus Tafinlar dabrafenib had “major added benefit” for women and “a non-quantifiable added benefit” for men. IQWiG said the company did not provide suitable data for monotherapy, as results from an indirect comparison with dacarbazine “allowed no reliable conclusions.”

The agency said the combination therapy provided significantly longer overall survival (OS) for women, though the same benefit was not proven in men. Mekinist also had “hint of an added benefit” for time to deterioration for pain, insomnia, appetite loss and diarrhea, but it is unclear whether the advantages exist only for women. Mekinist is a small molecule inhibitor of MAP kinase kinase 1 ( MAP2K1; MEK1) and MAP kinase kinase 2 ( MAP2K2; MEK2). Tafinlar is an oral BRAF protein kinase inhibitor. ...