- FDA Announcements
FDA Approved for RRMM: Pomalidomide (Pomalyst) + Dexamethasone
April 23, 2015; SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today 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: HR 0.45 two-sided 95% CI: 0.35-0.59 p < 0.001). Patients in the POMALYST plus low-dexamethasone arm had a 55% reduction in the risk of progression or death.
04/23/2015: : FDA Approval