Posted by Michael Wonder on 20 Nov 2019
Genmab announces European marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone in frontline multiple myeloma
19 November 2019 - Approval based on data from Phase III MAIA study.
Genmab announced today that the European Commission has granted marketing authorisation for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The EC approval follows a positive opinion issued for Darzalex by the CHMP of the EMA in October 2019.
