By Colin Kellaher
Genmab A/S (GMAB.KO, GMAB) on Tuesday said the European Commission approved the expanded use of Darzalex in a form of the blood cancer multiple myeloma.
The Copenhagen biotechnology company said the EC granted marketing authorization for Darzalex in combination with lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplant.
Johnson & Johnson's (JNJ) Janssen Biotech Inc. unit has an exclusive license to develop, manufacture and commercialize Darzalex under an August 2012 agreement with Genmab.
The European Medicines Agency's Committee for Medicinal Products for Human Use last month recommended approval of the additional indication.
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