Darzalex Now FDA Approved for Second Line Myeloma Treatment with Rev/Dex or Velcade/Dex

that the FDA has approved Darzalex (daratumumab) in two combinations (Dara/Rev/Dex or Dara/Velcade/Dex) in myeloma patients who have received at least one prior therapy. The approval is based on clinical studies showing that the addition of Darzalex to len/dex reduced the risk of disease progression or death by 63% compared to len/dex alone. The addition of Darzalex to Velcade/dex, reduced the risk of disease progression or death by 61% compared to Velcade/dex alone. Darzalex had been approved in these combinations for patients who had received three prior lines of therapy, so this is a major advance to bring the drug to earlier use in the clinic.

“While tremendous progress in the treatment of multiple myeloma has been made in the past decade, patients and their physicians continue to need new treatment options,” said Meletios A. Dimopoulos, M.D., Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Alexandra General Hospital, Athens, Greece, a DARZALEX clinical trial investigator. “With DARZALEX, we have a potential new backbone therapy, which has shown pronounced efficacy as either a single agent or in combination with standard of care regimens. The addition of DARZALEX also significantly improved progression-free survival in combination with two of the most widely used treatment classes, making it a versatile option for patients who have received at least one prior therapy.”

To find all Darzalex clinical trials, click here: Darzalex Clinical Trials