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FDA Approves Daratumumab Triplets for Relapsed Myeloma

Jan van de Winkel, PhD

Jan van de Winkel, PhD

The FDA has approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy, based on findings from the phase III POLLUX and CASTOR studies.1,2

In the POLLUX trial, adding daratumumab to lenalidomide and dexamethasone reduced the risk of progression or death by 63% versus lenalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma. In the CASTOR trial, the addition of daratumumab to bortezomib and dexamethasone reduced the risk of progression or death by 61% compared with the 2 drugs alone for patients with recurrent or refractory multiple myeloma.

“This is an exciting day for patients with multiple myeloma in the United States, who will now have the opportunity to receive Darzalex at an earlier point in treatment of their disease," Jan van de Winkel, PhD, CEO of Genmab, which codevelops daratumumab with Janssen, said in a statement. “We believe daratumumab has the potential to become a backbone therapy for multiple myeloma.”Click here to read the full article at OncLive.com


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