The drug is approved for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed and who have received at least two prior treatment regimens and have showed disease progression on their last regimen.
The company said that treatment with POMALYST has improved rates of overall survival and extended progression-free survival in patients who no longer respond to lenalidomide or bortezomib.
Health Canada also granted priority review status to POMALYST due to the high unmet medical need that exists and the clinical value that the treatment brings to patients and physicians.
Approval of the drug was based on the Phase III multi-center, randomized, open-label MM-003 trial, which enrolled about 455 patients who had received a median of five prior lines of therapy.
During this trial, median overall survival was improved for the pomalidomide plus low-dose dexamethasone arm, compared with the high-dose dexamethasone only arm (12.7 months versus 8.1 months).
The MM-003 trial also showed improved median progression-free survival of four months for patients with relapsed refractory multiple myeloma who were treated with pomalidomide plus low-dose dexamethasone, compared with 1.9 months for those treated with high-dose dexamethasone only.
The drug discovered and developed by Celgene is expected to be commercially available in March 2014.