US regulators have expanded the scope of Amgen’s cancer drug Kyprolis, approving its use in combination with dexamethasone or with lenalidomide/dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
The US Food and Drug Administration has also cleared Kyprolis (carfilzomib) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one or more lines of therapy, converting to the accelerated approval handed down in 2012 to a full one.
The new approval came on the back of Phase III date from the ENDEAVOR trial, which showed patients with R/R MM treated with Kyprolis and dexamethasone achieved 50 percent greater progression-free survival of 18.7 months compared to 9.4 months in those receiving Janssen’s Velcade (bortezomib) and dexamethasone, a current standard of care in relapsed multiple myeloma.
"Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs," said Sean E. Harper, R&D lead at Amgen. "Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer."