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FDA expands Darzalex approval for relapsed myeloma
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The FDA today expanded the approval of daratumumab as part of combination treatment for patients with relapsed or refractory myeloma.
The approval allows for use of daratumumab (Darzalex, Janssen) with pomalidomide (Pomalyst, Celgene) and dexamethasone for patients who received at least two prior therapies, including lenalidomide (Revlimid, Celgene) and a proteasome inhibitor.
The FDA based the approval on results of the phase 1 EQUULEUS study, which included 103 patients (median age, 64 years) with relapsed or refractory myeloma.
Patients had undergone a median four prior lines of therapy, and 74% had undergone prior autologous stem cell transplant. Eighty-nine percent of patients were refractory to lenalidomide, 71% were refractory to bortezomib (Velcade; Takeda), and 64% were refractory to bortezomib and lenalidomide.
Patients received 16 mg/kg of daratumumab — a human anti-CD38 monoclonal antibody — in combination with pomalidomide and dexamethasone.
Researchers reported a 59% (95% CI, 49.1-68.8) overall response rate, a 29% very good partial response rate, a 6% complete response rate and an 8% stringent complete response rate. Median time to response was 1 month (range, 0.9-2.8) and median duration of response was 13.6 months (range, 0.9+ to 14.6+).
The most common adverse events included infusion reactions (50%), fatigue (50%), upper respiratory tract infection (50%), cough (43%), diarrhea (38%), dyspnea (33%), nausea (30%), muscle spasms (26%), pyrexia (25%) and vomiting (21%).
Nearly half (49%) of patients experienced serious adverse reactions, and 7% of patients experienced grade 3 or grade 4 pneumonia. The most common grade 3 or grade 4 treatment-emergent hematology laboratory abnormalities included neutropenia (82%), lymphopenia (71%), anemia (30%) and thrombocytopenia (20%).
The FDA previously approved daratumumab for use with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, for patients with myeloma who received at least one prior treatment. The agent also is approved as monotherapy for patients with myeloma who received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent.
Darzalex is being developed under an agreement in which Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize the product.
Genmab will receive $25 million in milestone payments from Janssen in connection with the approval and first commercial sale of daratumumab under the newly expanded label, according to a Genmab-issued press release.
“We are very pleased to receive the FDA’s decision,” Jan van de Winkel, PhD, CEO of Genmab, said in the press release. “This offers another alternative to patients with multiple myeloma who haven’t seen lasting effects from other types of treatment.”