US regulators have approved Janssen's Darzalex (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adults with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy.

The combination has been approved in two carfilzomib dosing regimens, 70mg/m2 once weekly and 56mg/m2 twice weekly, based on positive results from the Phase III CANDOR and Phase Ib EQUULEUS studies.

The CANDOR study, which administered carfilzomib twice weekly, met its primary endpoint of progression free survival after a median follow-up of 16.9 months and 16.3 months for the DKd and Kd arms, respectively. The median PFS had not been reached in the DKd arm and was 15.8 months in the Kd arm, representing a 37% reduction in the risk of disease progression or death for patients treated with DKd versus Kd.

“The significant increase in progression-free survival (PFS) seen among patients receiving the DKd regimen supports the use of this new combination for patients with relapsed and refractory multiple myeloma. We continue to advance effective regimens for the most critical patients who have already relapsed,” said Saad Usmani, division chief of Plasma Cell Disorders, Atrium Health’s Levine Cancer Institute, and principal investigator of the CANDOR study.

"The DKd regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug-based therapy, such as lenalidomide-containing regimens, and therefore new therapeutic options are needed."

Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab in August 2012.