Janssen/Genmab's Darzalex has become the first monoclonal antibody to be approved in the US to treat patients newly diagnosed with multiple myeloma.

The US Food and Drug Administration has cleared the drug’s use in combination with Velcade (bortezomib), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone (collectively VMP) in the first-line setting for those who are ineligible for autologous stem cell transplant (ASCT).

The decision follows results of the Phase III ALCYONE study, recently published in the New England Journal of Medicine, which showed that combining Darzalex (daratumumab) with VMP reduced the risk of disease progression or death by 50 percent versus VMP alone.

Also, median progression-free survival (PFS) for Darzalex-VMP had not yet been reached, compared to a median PFS of 18.1 months for patients who received VMP alone.

"A patient's best chance at lasting remission often begins with a durable response to frontline therapy, because multiple myeloma can become more difficult to treat after relapse," said Maria-Victoria Mateos, director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain and ALCYONE primary investigator.

"Combination therapy with daratumumab resulted in deep and durable responses in newly diagnosed patients with multiple myeloma who are transplant ineligible, supporting this regimen as an important new treatment option for these patients."

The approval marks the fifth indication for Darzalex in the US, having been first cleared in 2015 to treat relapsed or refractory multiple myeloma.