Dr. Fonseca on FDA Approval of Daratumumab Triplets in Multiple Myeloma

Rafael Fonseca, MD, professor of Medicine, Mayo Clinic, discuses the recent FDA approval of daratumumab (Darzalex) in combination with lenalidomide and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy.

The approval is based on findings from the phase III POLLUX and CASTOR studies. 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.

Additionally, Fonseca says these approvals are a major step forward because the triplet regimens have the ability to induce deep responses in patients experiencing relapse. He added that, from a safety viewpoint, daratumumab is generally well tolerated following the first infusion in patients. For a patient who can maintain disease control in the long-term with this regimen, it is a very exciting mark in the field.