Genmab, Janssen Get CHMP Positive Option for Expanded Darzalex Use

Genmab A/S (GMAB.KO, GMAB) Friday said the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended expanded approval of Darzalex in a form of multiple myeloma.
The Copenhagen biotechnology company said the recommendation covers Darzalex in combination with lenalidomide and dexamethasone for newly diagnosed adults with multiple myeloma who are ineligible for autologous stem-cell transplant.
Genmab’s licensing partner, Johnson & Johnson’s (JNJ) Janssen Biotech Inc. unit, had filed for approval of the new indication in March. Janssen has an exclusive license to develop, manufacture and commercialize Darzalex under an August 2012 agreement with Genmab.
The European Commission, which generally follows the CHMP’s recommendations, is expected to make a final decision in the coming months, Genmab said.
Darzalex is already approved in the European Union for several indications in multiple myeloma, a cancer that forms in a type of white blood cells called plasma cells and causes cancer cells to accumulate in the bone marrow.

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