FDA Approves Daratumumab Combination for Newly Diagnosed Transplant-Ineligible Patients With Multiple Myeloma
Posted: Friday, June 28, 2019
On June 27, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The application received approval through the FDA’s Real-Time Oncology Review pilot program.
The approval is based on results from the phase III MAIA (ClinicalTrials.gov identifier NCT02252172) clinical study, which showed that daratumumab plus lenalidomide and dexamethasone significantly reduced the risk of disease progression or death by 44% compared with lenalidomide and dexamethasone alone. The addition of daratumumab resulted in deeper responses compared with lenalidomide and dexamethasone alone, including increased rates of complete response or better (48% vs. 25%), very good partial response or better (79% vs. 53%), and overall response (93% vs. 81%). Daratumumab plus lenalidomide and dexamethasone induced a more than threefold higher rate of minimal residual disease negativity than lenalidomide and dexamethasone alone (24% vs. 7%).
The most frequent (≥ 20%) adverse reactions 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.
