IQWiG says added benefit of GSK’s Tafinlar not proven

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether UK pharma giant GlaxoSmithKline’s (LSE: GSK) drug Tafinlar (dabrafenib) offers an added benefit over the appropriate comparator therapy.

According to the findings, an added benefit of dabrafenib is not proven: Regarding mortality, symptoms, health-related quality of life and treatment discontinuation due to side effects, no advantage can be derived from the dossier. Concerning other side effects, the data were too uncertain to allow drawing any conclusions.

Dabrafenib is an option for adult patients with melanoma that has a certain abnormal protein (BRAF V600 mutation) and that is unresectable or has already formed metastases. The Federal Joint Committee (G-BA) has specified the drug dacarbazine as the appropriate comparator therapy.