IQWiG rejects GSK's Tafinlar for melanoma
Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) had "no additional benefit" vs. dacarbazine to treat unresectable or metastatic melanoma with a BRAF V600 mutation. IQWiG said overall survival (OS) data did not show significant differences between Tafinlar and dacarbazine. At the time of Tafinlar's assessment, the Phase III BREAK-3 trial comparing the oral BRAF protein kinase inhibitor with dacarbazine had not yet reached the required number of deaths for a final OS analysis. The committee said there were also no "relevant differences" in symptoms between Tafinlar and dacarbazine. Comments are due Jan. 23, with a final assessment from Germany's Federal Joint Committee (G-BA) expected in mid-March. The European Commission approved Tafinlar in September. ...