FDA Grants Priority Review to Front-Line Combination Therapy for Multiple Myeloma
Posted: Friday, January 26, 2018
On January 19, 2018, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib, melphalan, and prednisone (VMP) treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.
The sBLA submission was based on data from the phase III ALCYONE study of daratumumab in combination with VMP in the front-line treatment of multiple myeloma. Patients were randomized to receive nine cycles of either VMP combined with daratumumab or VMP alone. In the daratumumab treatment arm, progression-free survival was doubled compared with that with the standard of care regimens. At 16.5 months, the daratumumab arm showed a 50% reduction in the risk of disease progression or death, with the most common adverse events (≥ 20%) being neutropenia, thrombocytopenia, anemia, peripheral sensory neuropathy, upper respiratory tract infection, diarrhea, pyrexia, and nausea.
These data were presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition (LBA 4) as well as published in The New England Journal of Medicine.
