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Amgen’s Kyprolis and Janssen’s Darzalex combination approved by the US FDA for multiple myeloma

Janssen and Amgen have announced that they have received the approval for the combination treatment of Darzalex (daratumumab), Kyprolis (carfilzomib), and dexamethasone (DKd) for patients suffering from refractory/relapsed multiple myeloma. The US Food and Drug Administration has approved for patients who have received at least one to three treatment lines.

The approval is based on the Phase 3 CANDOR study. A multicentre study, evaluated the combination treatment in 466 patients with relapsed/refractory multiple myeloma, who were prior treated with one to three therapies. The trial was designed to compare the efficacy of combination treatment of Darzalex, Kyprolis, and dexamethasone (DKd) versus Kyprolis, and dexamethasone (Kd). The progression-free survival was considered as the primary endpoint; there was a 37% reduction in the risk of disease progression in DKd arm compared to Kd alone.

CANDOR study was sponsored by Amgen and was co-funded by Janssen.

Janssen had a commercial development agreement for Darzalex with Genmab. The drug acts by binding with CD38 and thereby inhibiting the growth of tumors. Janssen stated that more than 143,000 patients were treated with Darzalex to date.

Kyprolis has been approved for treating multiple myeloma in 2012, and 150,000 patients received treatment with Kyprolis until now.

About multiple myeloma:

Multiple myeloma is a blood cancer which impacts the plasma cells, a type of white blood cells. The cancer accounts for one percent of total cancers and have high rate of mortality. Annually, 106,000 deaths are reported worldwide because of multiple myeloma.


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