FDA Expands Daratumumab Approval for Multiple Myeloma
The FDA approved daratumumab in combination with pomalidomide and dexamethasone for the third-line treatment of patients with multiple myeloma.
The US Food and Drug Administration (FDA) approved daratumumab in combination with pomalidomide and dexamethasone for the third-line treatment of patients with multiple myeloma (MM) who received prior therapy with lenalidomide and a proteosome inhibitor.1
Daratumumab, an anti-CD38 antibody, is already approved as a single agent for fourth-line treatment of patients who have received prior therapy with an immunomodulatory agent and a proteosome inhibitor, and in combination with lenalidomide or bortezomib and dexamethasone for patients who have received at least 1 prior therapy.
The FDA approved this indication for daratumumab based on data from the phase 1b EQUULEUS trial, which treated 103 patients with MM who received a prior immunomodulatory agent and proteasome inhibitor with daratumumab plus pomalidomide and low-dose dexamethasone until disease progression.
The median number of prior therapies was 4; 74% of patients had previously undergone an autologous stem cell transplant.
The study demonstrated an overall response rate of 59.2% (95% CI, 49.1-68.8%) with a median time to response of 1 month (range, 0.9 to 2.8 months) with the triplet.
A complete response was achieved by 5.8% of patients, stringent complete response by 7.8%, very good partial response was achieved by 28.2% of patients, and partial response by 17.5%. The median duration of response was 13.6 months (range, 0.9+ to 14.6+ months).
The safety profile was similar to what is expected with daratumumab monotherapy and the combination of pomalidomide with dexamethasone. Serious adverse events (AEs) occurred in 49% of patients, which included pneumonia among 7%.
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The most common AEs were infusion reactions, diarrhea, constipation, nausea, vomiting, fatigue, pyrexia, upper respiratory tract infection, muscle spasms, back pain, arthralgia, dizziness, insomnia, cough, and dyspnea. The rate of discontinuation due to AEs was 13%.
- DARZALEX (daratumumab) approved by the US FDA in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least two prior therapies [news release]. Horsham, PA: Janssen; June 16, 2017. http://www.janssen.com/darzalex-daratumumab-approved-us-fda-combination-pomalidomide-and-dexamethasone-patients-multiple. Accessed June 19, 2017.