EC quickly follows FDA in approving Darzalex combo in front-line setting

31 August 2018

Danish biotech Genmab (Nasdaq Copenhagen: GEN) and its commercialization partner Janssen Biotech promise sales of Darzalex (daratumumab) in the front-line setting will start soon after the European Commission (EC) gave it the green light.

The EC has granted marketing authorization for the drug in combination with bortezomib, melphalan and prednisone for the treatment of newly-diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant.

This comes two months after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended that this indication be approved, and four months on from the US Food and Drug Administration (FDA) giving its approval.

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