2 June 2016 - New analyses from the commenting procedure showed further advantages of the drug.

Cobimetinib hemifumarate (Cotellic) has been approved since November 2015 in combination with vemurafenib for the treatment of adults with advanced, i.e. metastatic or unresectable, melanoma with a BRAF V600 mutation. In a dossier assessment from March 2016, the German IQWiG found both advantages and disadvantages of cobimetinib hemifumarate in combination with vemurafenib in comparison with the appropriate comparator therapy vemurafenib alone. This resulted in an indication of a minor added benefit.

In the subsequent commenting procedure, the drug manufacturer presented further data analyses, which were now included in the assessment in a so-called addendum. This increased the extent of the added benefit: there is now an indication of a considerable added benefit of cobimetinib hemifumarate plus vemurafenib in comparison with vemurafenib monotherapy.

For more details, go to: https://www.iqwig.de/en/press/pressemitteilungen/press-releases/cobimetinib-in-advanced-melanoma-with-braf-v600-mutation-added-benefit-now-considerable.7384.html