By Colin Kellaher

 

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.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

October 18, 2019 07:35 ET (11:35 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
Johnson and Johnson (NYSE:JNJ)
Graphique Historique de l'Action
De Fév 2024 à Mar 2024 Plus de graphiques de la Bourse Johnson and Johnson
Johnson and Johnson (NYSE:JNJ)
Graphique Historique de l'Action
De Mar 2023 à Mar 2024 Plus de graphiques de la Bourse Johnson and Johnson