Posted by Michael Wonder on 26 Jul 2016
Daratumumab receives breakthrough therapy designation from U.S. Food and Drug Administration in combination with standard of care regimens for previously treated multiple myeloma
26 July 2016 - Marks second breakthrough therapy designation for daratumumab.
Genmab announced today that the U.S. FDA has granted breakthrough therapy designation for Darzalex (daratumumab) injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
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.
"This is the second time daratumumab has earned the distinction of a breakthrough therapy designation. We are pleased that the FDA continues to recognize the potential of daratumumab to help patients with multiple myeloma. We continue to work with our strategic partner Janssen and the regulatory authorities to advance daratumumab to bring this treatment to more patients suffering from multiple myeloma as quickly as possible," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
