Celgene announced that its results from its international Phase 3 study have fulfilled the requirements for accelerated approval for Pomalyst (pomalidomide). Pomalyst is a thalidomide analogue approved for patients with multiple myeloma who have received at least two prior therapies (including lenalidomide and bortezomib), and have shown disease progression on or within 60 days of completion of the last therapy.
MM-003 evaluated Pomalyst plus low-dose dexamethasone vs. high-dose dexamethasone in patients with relapsed/refractory multiple myeloma. Median progression-free survival (PFS), the study’s primary endpoint, was significantly longer with Pomalyst plus low-dose dexamethasone than high-dose dexamethasone (3.6 months vs. 1.8 months; HR 0.45, 95% CI: 0.35-0.59; P<0.001). The Pomalyst plus low-dose dexamethasone arm demonstrated a 55% reduction in the risk of progression of death. Also, median overall survival (OS) was higher in Pomalyst plus low-dose dexamethasone than high-dose dexamethasone (12.4 months vs. 8 months; HR 0.70, 95% CI: 0.54-0.92; P=0.009). Pomalyst plus low-dose dexamethasone group demonstrated a 30% reduction in the risk of death.
This labeling update, approved by the Food and Drug Administration (FDA), confirms the survival benefits of Pomalyst. Pomalyst was initially approved in February 2013 based on the results of its Phase 2 MM-002 study.
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