Posted by Michael Wonder on 22 Nov 2016
Genmab announces U.S. FDA approval of Darzalex (daratumumab) for relapsed multiple myeloma
21 November 2016 - Darzalex (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for relapsed or refractory multiple myeloma.
Genmab announced today the U.S. FDA has approved the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
In July 2016, daratumumab was granted a breakthrough therapy designation in this patient population. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialise Darzalex.
