Darzalex Combined with Revlimid and Dexamethasone Approved as First-Line Treatment for Patients with MM Ineligible for Transplant

On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma (MM) who are ineligible for autologous stem-cell transplantation. This is the sixth indication for daratumumab in MM and the second for newly diagnosed patients.

This latest approval was based on results from the phase 3 MAIA clinical trial of 737 patients with newly diagnosed MM who were not candidates for high-dose chemotherapy and autologous stem-cell transplantation. Patients were randomized in a 1:1 ratio to daratumumab plus lenalidomide and dexamethasone or lenalidomide and dexamethasone alone.

Results showed an improvement in progression-free survival (PFS) with the addition of daratumumab. Median PFS had not been reached in the daratumumab arm and was 31.9 months in the lenalidomide plus dexamethasone arm (hazard ratio, 0.56; 95% confidence interval, 0.43-0.73; P <.0001). In addition, researchers reported higher rates of complete response or better (48% vs 25%, respectively) and overall response (93% vs 81%, respectively) in the daratumumab arm, as well as a higher rate of minimal residual disease negativity (24% vs 7%, respectively).

The most common (≥20%) adverse events associated with dara­tumu­mab-based therapy were infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper respiratory tract infection, bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral sensory neuropathy, dysp­nea, and cough.

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