Darzalex Combined with Pomalidomide and Dexamethasone Approved for Relapsed/Refractory Multiple Myeloma

Web Exclusives - FDA Approvals

On June 16, 2017, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with pomalidomide (Pomalyst) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 2 previous therapies, including lenalidomide (Rev­limid) and a proteasome inhibitor.

“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, Genmab.

The approval was based on data from the phase 1 EQUULEUS clinical trial involving 103 patients with multiple myeloma who received previous therapy. Patients received 16 mg/kg of daratumumab plus pomalidomide and dexamethasone until disease progression. The primary efficacy end point was the overall response rate (ORR).

The ORR was 59.2%. The stringent complete response rate was 7.8%, the complete response rate was 5.8%, the very good partial response rate was 28.2%, and the partial response rate was 17.5%.

The most common (≥20%) all-grade adverse reactions in patients who received daratumumab plus pom­alidomide and dexamethasone included infusion reactions, diarrhea, constipation, nausea, vomiting, fatigue, pyrexia, upper respiratory tract infection, muscle spasms, back pain, arthralgia, dizziness, insomnia, cough, and dyspnea. Overall, 49% of patients had serious adverse reactions, and 13% of patients discontinued therapy because of adverse reactions.

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Last modified: August 10, 2017
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