Posted by Michael Wonder on 27 Mar 2019
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in combination with bortezomib, thalidomide and dexamethasone in frontline multiple myeloma
26 March 2019 - Submission based on data from Phase III CASSIOPEIA study.
Genmab announced today that its licensing partner, Janssen Biotech has submitted a supplemental biologics license application to the U.S. FDA for the use of daratumumab (Darzalex) in combination with bortezomib, thalidomide and dexamethasone as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.
In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab.
