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Janssen/Genmab Win 1st Anti-CD38 In Multiple Myeloma

 
• By Donna Young

Johnson & Johnson Inc.'s subsidiary Janssen Biotech Inc. and its partner Genmab AS were the latest beneficiaries of the FDA's swift acting Office of Hematology and Oncology Products, which approved the firms' multiple myeloma drug Darzalex (daratumumab) well ahead of its March 9, 2016 expected goal date and just two months after the FDA accepted the medicines biologics license application (BLA).

Johnson & Johnson Inc.'s subsidiary Janssen Biotech Inc. and its partner Genmab AS were the latest beneficiaries of the FDA's swift acting Office of Hematology and Oncology Products, which approved the firms' multiple myeloma drug Darzalex (daratumumab) well ahead of its March 9, 2016 expected goal date and just two months after the FDA accepted the medicines biologics license application (BLA).

The companies pointed out that Darzalex, which is administered as an intravenous infusion, is the first human anti-CD38 monoclonal antibody approved anywhere in the world to treat multiple myeloma, an...

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