Drug maker Celgene Corp. (CELG) said Tuesday that Health Canada has approved Pomalyst oral therapy (pomalidomide capsules) in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen. The company expects that Pomalyst will be commercially available in March 2014.
The company said Treatment with Pomalyst has been shown to improve rates of overall survival and extend progression-free survival in patients who no longer respond to lenalidomide or bortezomib.
Pomalyst received priority review status by Health Canada due to the high unmet medical need that exists and the clinical value that the treatment brings to patients and physicians.
The Health Canada approval of POMALYST was based on the MM-003 pivotal study, which was published in The Lancet Oncology in October 2013. The MM-003 pivotal study demonstrated significantly improved median progression-free survival of four months (p<0.001) 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.
Pomalyst (pomalidomide capsules) is an oral immunomodulatory drug. Through its targeted action on treatment-resistant myeloma cells, Pomalyst inhibits tumour cell growth, triggers cell death and enhances the body's own immune response to the tumour. Pomalyst was discovered and developed by Celgene, and represents the third novel oral treatment for multiple myeloma to be approved in Canada.
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