IQWiG now finds 'considerable added benefit' for Roche's Cotellic

In a dossier assessment from March 2016, the German Institute for Quality and Efficiency in Health Care (IQWiG) found both advantages and disadvantages of Cotellic (cobimetinib), Roche’s (ROG: SIX) drug approved for metastatic or unresectable, melanoma with a BRAF V600 mutation, in combination with vemurafenib in comparison with the appropriate comparator therapy vemurafenib alone. This resulted in an indication of a minor added benefit (TPL March 21).

In the subsequent commenting procedure, Roche 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 plus vemurafenib in comparison with vemurafenib monotherapy.

Third data cut-off of the approval study decisive