17 March 2016 - The drug manufacturer presented further analyses; the additional disadvantages outweigh the survival advantage.

Regorafenib (Stivarga) has been approved since 2013 for adults with metastatic colorectal cancer in whom previous treatments are no longer effective or for whom these alternatives are not an option. In two previous benefit assessments conducted in early 2014 and in early 2016, the German Institute for Quality and Efficiency in Health Care (IQWiG) found a hint of a minor added benefit of the drug over the appropriate comparator therapy: A survival advantage was accompanied by more frequent severe side events. However, IQWiG had also criticised in these assessments that the manufacturer had not adequately analysed the data on patient-reported outcomes (symptoms and quality of life).

In the commenting procedure after the second dossier assessment, the manufacturer presented changed analyses on health-related quality of life and symptoms. The Federal Joint Committee (G-BA) then commissioned IQWiG to conduct a supplementary assessment, a so-called addendum. According to the findings, an added benefit of the drug in comparison with the appropriate comparator therapy “best supportive care” (BSC) is no longer proven.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/addendum-on-regorafenib-in-metastatic-colorectal-cancer-added-benefit-no-longer-proven.7216.html