FDA Approves Daratumumab for ASCT-Eligible Multiple Myeloma


The approval is based on findings showing patients on the drug plus VTd had a 53% reduction in risk of disease progression or death, compared to lone VTd.


The US Food and Drug Administration (FDA) has approved daratumumab (DARZALEX) combination regimen for the treatment of newly diagnosed, autologous stem cell transplant (ASCT)-eligible patients with multiple myeloma.

The monoclonal antibody from Janssen Pharmaceuticals was approved based on the results of the phase 3 CASSIOPEIA trial showing the addition of daratumumab to bortezomib, thalidomide, and dexamethasone (VTd) before and after ASCT resulted in higher stringent complete response (sCR) rates and improved progression-free survival (PFS) versus lone VTd.

The addition of daratumumab to VTd was associated with a 53% reduction in risk of disease progression or death versus VTd alone (HR, 0.47; 95% CI, 0.33 — 0.67; P <.0001). Daratumumab plus VTd was also associated with a complete response rate of 13 percentage points greater than VTd alone (39% vs 26%; OR, 1.82; 95% CI, 1.04 — 1.92).

The most frequent adverse reactions in treated patients included infusion reactions, nausea, pyrexia, upper respiratory tract infection and bronchitis. Serious adverse reactions with—a 2% greater incidence in the treated arm compared to control&mdash;included bronchitis and pneumonia, respectively. In the treatment arm, infusion-related reactions occurred in 35% of patients.

The approval comes 3 months following daratumumab’s indication as a multiple myeloma therapy for patients ineligible for ASCT. Multiple myeloma is a rare form of cancer associated with damaging effects to patients’ bones, immune system, kidneys, and red blood cell counts.

Paul Giusti, president and chief executive officer of the Multiple Myeloma Research Foundation, expressed thrill with the new combination therapy option.

"The Multiple Myeloma Research Foundation and Janssen share a mutual focus on accelerating development of new effective treatment options for patients, Giusti said in a statement. “We are grateful for Janssen's continued commitment to myeloma patients and their families."

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