Market Overview

Genmab Announces FDA Grants Priority Review for Daratumumab for Double Refractory Multiple Myeloma


Genmab A/S (OTC: GNMSF) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for daratumumab. The BLA is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. A rolling BLA submission was started by Genmab's licensing partner, Janssen Biotech, Inc. in June and was completed on July 9, 2015. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy.  The FDA aims to complete its review of the daratumumab BLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.  

"We are pleased that the FDA has granted Priority Review for daratumumab in double refractory multiple myeloma.  If

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Posted-In: News FDA Press Releases


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