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FDA expands Darzalex approval for multiple myeloma
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The FDA approved the use of daratumumab in combination with lenalidomide and dexamethasone for treatment of patients with newly diagnosed multiple myeloma who are not eligible for transplant.
This is the sixth indication for daratumumab (Darzalex, Janssen) in multiple myeloma and the second for newly diagnosed patients.
“Multiple myeloma can become more difficult to treat after relapse, so it is important that patients receive an efficacious upfront therapy with a goal of extending their first remission period,” Saad Z. Usmani, MD, FACP, chief of plasma cell disorders and director of clinical research in hematologic malignancies at Levine Cancer Institute at Atrium Health, lead investigator of the MAIA study and a HemOnc Today Editorial Board Member, said in a Janssen-issued press release. “This regimen offers an important frontline treatment option for this patient population.”
Daratumumab is a CD38-directed antibody.
The FDA based the new indication on results of the randomized phase 3 MAIA study, which included 737 patients (median age, 73 years; range, 45-90) with newly diagnosed multiple myeloma who were ineligible for high-dose chemotherapy and autologous stem cell transplant.
Investigators randomly assigned patients to lenalidomide and dexamethasone with or without daratumumab in 28-day cycles. Treatment continued until disease progression or unacceptable toxicity.
Results showed the addition of daratumumab to lenalidomide (Revlimid, Celgene) and dexamethasone reduced the risk for disease progression or death by 44% for newly diagnosed, transplant-ineligible patients (HR = 0.56; 95% CI, 0.43-0.73).
Researchers observed longer median PFS (not reached vs. 31.9 months) and higher rates of complete response or better (48% vs. 25%) and overall response (93% vs. 81%), and a higher rate of minimal residual disease negativity (24% vs. 7%) in the daratumumab group.
Daratumumab exhibited a safety profile consistent with that observed in prior studies.
The most frequent adverse reactions reported among daratumumab-treated patients 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 that occurred more frequently among daratumumab-treated patients included pneumonia (15% vs. 8%), bronchitis (4% vs. 2%) and dehydration (2% vs. <1%).
The most common treatment-emergent grade 3/grade 4 hematology laboratory abnormalities included neutropenia (56%), lymphopenia (52%) and leukopenia (35%).
“For patients with multiple myeloma, optimizing response to frontline treatment is critical,” Paul Giusti, president and CEO of Multiple Myeloma Research Foundation, said in the release. “This latest indication for Darzalex is a promising development for the myeloma community.”