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FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma

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Today, 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 (ASCT).

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 clinical trial, which showed that the addition of daratumumab to lenalidomide/dexamethasone significantly reduced the risk of disease progression or death by 44% compared to treatment with lenalidomide/dexamethasone alone. Data from the MAIA study were recently published in The New England Journal of Medicine, and were presented by Facon et al at the 2018 American Society of Hematology (ASH) Annual Meeting (Abstract LBA2).

More About MAIA

The randomized, open-label, multicenter phase III study included 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45 to 90 years old. Patients were randomly assigned to receive either daratumumab plus lenalidomide/dexamethasone or lenalidomide/dexamethasone alone in 28-day cycles. In the daratumumab plus lenalidomide/dexamethasone treatment arm, patients received 16 mg/kg of intravenous daratumumab weekly for cycles 1 to 2, every 2 weeks for cycles 3 to 6, and every 4 weeks for cycle 7 and thereafter. Patients in the daratumumab plus lenalidomide/dexamethasone and lenalidomide/dexamethasone arms received 25 mg of lenalidomide on days 1 to 21 of each 28-day cycle and dexamethasone at 40 mg once a week for each cycle. Patients in both treatment arms continued until disease progression or unacceptable toxicity.

At a median follow-up of 28 months, results showed daratumumab plus lenalidomide/dexamethasone significantly reduced the risk of disease progression or death by 44% in patients with newly diagnosed multiple myeloma who are transplant-ineligible compared to treatment with lenalidomide/dexamethasone alone (hazard ratio [HR] = 0.56, 95% confidence interval [CI] = 0.43–0.73; P < .0001). The median progression-free survival for daratumumab plus lenalidomide/dexamethasone has not yet been reached, compared to 31.9 months for patients who received lenalidomide/dexamethasone alone. The addition of daratumumab resulted in deeper responses compared to lenalidomide/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/dexamethasone induced a more than threefold higher rate of minimal residual disease negativity compared to lenalidomide/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. Serious adverse reactions with a 2% greater incidence in the daratumumab plus lenalidomide/dexamethasone arm compared to the lenalidomide/dexamethasone arm were pneumonia (15% vs 8%), bronchitis (4% vs 2%), and dehydration (2% vs < 1%), respectively. Treatment-emergent grade 3/4 hematology laboratory abnormalities (≥ 20%) were neutropenia (56%), lymphopenia (52%), and leukopenia (35%). The safety profile of daratumumab was consistent with that of previous studies.

View the prescribing information for daratumumab

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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