POMALYST Meets Accelerated Approval Requirements for Multiple Myeloma
POMALYST for relapsed/refractory multiple myeloma has met its accelerated approval requirements.
The results from an international phase 3 study of POMALYST with low-dose dexamethasone compared with high-dose dexamethasone for patients with relapsed/refractory multiple myeloma (MM-003) indicate that POMALYST has met its accelerated approval requirements.
POMALYST with dexamethasone is approved for patients with multiple myeloma who have received at least two prior therapies that include lenalidomide and a proteasome inhibitor and have had disease progression within 60 days of completion of their last treatment.
The MM-003 study indicated that patients treated with POMALYST with low-dose dexamethasone reduced their risk of progression or death by 55%.
“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, PhD, President, Global Hematology and Oncology for Celgene, in a press release.
RELATED: Bortezomib with Hemodialysis Improves Renal Function in Multiple Myeloma
The prespecified, final analysis for overall survival (OS) showed a median OS of 12.4 months for patients receiving POMALYST plus low-dose dexamethasone (95% CI: 10.4, 15.3), the OS for patients who received high-dose dexamethasone was 8 months (95% CI: 6.9, 9.0).
This survival benefit was statistically significant (HR 0.70 [two-sided 95% CI: 0.54, 0.92], p=0.009) despite the fact that 53% of patients in the high-dose dexamethasone arm received subsequent POMALYST treatment.
The hazard ratio of 0.70 equated to a 30% reduction in the risk of death for patients receiving POMALYST plus low-dose dexamethasone.