First approval for Darzalex in a frontline indication

8 May 2018

Darzalex (daratumumab) is the first monoclonal antibody to receive US Food and Drug Administration approval to treat multiple myeloma and reached blockbuster status in 2017, Danish biotech Genmab (OMX: GEN) announced today.

The approval is for Darzalex in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of newly-diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT). Today's FDA approval marks the fifth indication for Darzalex.

The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ) in November 2017. The US FDA subsequently granted priority review to the sBLA, with a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2018. In August 2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize daratumumab. J&J posted sales of $432 million for Darzalex in the first quarter of this year.

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