Celgene Corporation announced it has fulfilled the accelerated approval requirements for POMALYST (pomalidomide) based on results from MM-003, an international phase III study of POMALYST plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma patients. POMALYST, in combination with dexamethasone is approved for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
"There remains a significant unmet need for relapsed/refractory multiple myeloma patients. POMALYST has been able to help thousands of patients since its approval in 2013 and this data now confirms its survival benefits," said Jacqualyn A. Fouse, Ph.D., President, Global Hematology and Oncology for Celgene. "This label update provides important information about a key product in our industry-leading portfolio of therapies for patients with multiple myeloma."
In the MM-003 study, median progression-free survival (PFS), the primary endpoint of the study, was significantly longer with POMALYST plus low-dose dexamethasone (3.6 months) than high-dose dexamethasone (1.8 months). Patients in the POMALYST plus low-dexamethasone arm had a 55% reduction in the risk of progression or death.
The pre-specified, final analysis for overall survival (OS) showed a median overall survival for the POMALYST plus low-dose dexamethasone arm of 12.4 months, compared to the high-dose dexamethasone arm of 8 months. This survival benefit was statistically significant even though 53% of patients in the high-dose dexamethasone arm had subsequently received POMALYST.
POMALYST was initially approved by the FDA in February 2013 under the agency's accelerated approval program based on the phase II study, MM-002.
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