The US Food and Drug Administration (FDA) approved the combination of daratumumab (Darzalex, Genmab) with pomalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma, according to a press release from the drug’s manufacturer.
Patients with relapsed or refractory myeloma who have had at least two prior therapies including lenalidomide and a proteasome inhibitor are now eligible to receive daratumumab, the first monoclonal antibody to receive approval for the treatment of multiple myeloma.
The FDA based its approval on the results of the phase I EQUULEUS study. The open-label study included 103 patients with multiple myeloma who received 16 mg/kg daratumumab combined with pomalidomide and dexamethasone.
The overall response rate for the drug combination was 59% (95% CI, 49.1%–68.8%). Eight percent of patients achieved stringent complete response, 6% of patients achieved a complete response, and more than one-quarter (28%) of patients achieved a very good partial response. The median time to response to treatment was 1 month, and the median duration of response was longer than 1 year (13.6 months).
Patients treated with the daratumumab combination reported infusion reactions (50%), diarrhea (38%), nausea (30%), vomiting (21%), fatigue (50%), pyrexia (25%), upper respiratory tract infection (50%), muscle spasms (26%), cough (43%) and dyspnea (33%).
About one-half of patients experienced a serious adverse reaction to the drug combination. The most common grade 3/4 treatment-related hematologic events were lymphopenia, neutropenia, thrombocytopenia, and anemia.
“We are very pleased to receive the FDA’s decision to approve Darzalex in combination with pomalidomide and dexamethasone. This offers another alternative to patients with multiple myeloma who haven’t seen lasting effects from other types of treatment,” said Jan van de Winkel, PhD, chief executive officer of Genmab, in a press release.
Daratumumab is also approved in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma who have failed on at least one prior therapy. Both of those approvals were based on phase III data.