Daratumumab Receives Breakthrough Therapy Designation From US Food and Drug Administration

2 05 2013

New Drug Approvals

b-cell-lg

May 1, 2013

Genmab A/S announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and IMiD. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.

Read more: http://www.nasdaq.com/article/daratumumab-receives-breakthrough-therapy-designation-from-us-food-and-drug-administration-20130501-00928#ixzz2S6OMoCQH

 

Daratumumab is an investigational anti-cancer drug. It binds to CD38.Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson &…

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