European Commission grants expanded label for Darzalex

Denmark’s Genmab (OMX: GEN) said on Friday that the European Commission (EC) has granted a new marketing authorization for Darzalex (daratumumab.

This is for the use of the drug in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

The initial Marketing Authorisation was granted in May 2016 for daratumumab as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.