Posted by Michael Wonder on 17 Aug 2016
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in relapsed multiple myeloma
17 August 2016 - sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma.
Genmab announced today that its licensing partner, Janssen Biotech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for the use of daratumumab (Darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy.
In July 2016, daratumumab was granted a breakthrough therapy designation in this patient population. The submission of the application triggers milestone payments totaling USD 15 million to Genmab from Janssen. The milestone payments were included in Genmab's financial guidance for 2016 that was published on August 9, 2016.
In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
