These data supported the recent submission to the U.S. Food and Drug Administration (FDA) seeking approval for DARZALEX FASPRO® in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) for the treatment of patients with AL amyloidosis. The submission is being reviewed under the Real-Time Oncology Review Program to seek the first approval for any drug to treat this disease.
"AL amyloidosis is a rare blood disorder in which abnormal proteins build up in the tissues and organs and eventually cause major organ deterioration," said study investigator, Raymond L. Comenzo, M.D., Director, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center. "The data being presented at ASH show the potential of this new treatment regimen. Compared to VCd alone, the D-VCd regimen increased hematologic response rates and prolonged major organ deterioration-progression-free survival (MOD-PFS) in patients with AL amyloidosis."