Genmab, Janssen Get CHMP Positive Option for Expanded Darzalex Use
18 Octobre 2019 - 01:50PM
Dow Jones News
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
Johnson and Johnson (NYSE:JNJ)
Graphique Historique de l'Action
De Mar 2023 à Mar 2024