Health Canada has approved Celgene‘s POMALYST oral therapy (pomalidomide capsules) in combination with dexamethasone for treatment of patients with multiple myeloma.

POMALYST is approved for patients for whom both lenalidomide and bortezomib have failed and who have received at least two prior treatments and shown disease progression on their last regimen.

It has been observed 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.

The capsules received priority review status from Health Canada due to the high unmet medical need that exists and the clinical value that the treatment brings to patients and physicians.

Discovered and developed by Celgene, POMALYST is expected to be commercially available in March.

Multiple-myeloma-treating haematologist and researcher in Toronto Donna Reece said the approval of POMALYST is excellent news for the multiple myeloma community.

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"Until now, there have been no approved options for patients whose disease has progressed despite available treatments," Reece said.

"With POMALYST, we have a new option that extends periods of remission, is generally well-tolerated and can be taken in the convenience of a patient’s home."

The approval was based on the Phase III multi-centre, randomised, open-label MM-003 trial, which enrolled a total of 455 patients who had received a median of five prior lines of therapy.

In the 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 approval of POMALYST marks another important milestone for Canadian patients and brings us one step closer to transforming multiple myeloma into a long-term, manageable disease."

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 company said that treatment with POMALYST has been generally well-tolerated and the most commonly reported Grade 3 or 4 adverse reactions outlined in the trial included: anemia, neutropenia and thrombocytopenia.

Other Grade 3 or 4 adverse events reported in this trial were pneumonia, fatigue, pyrexia and peripheral edema.

Myeloma Canada co-founder and chief scientific advisor Aldo Del Col said: "The approval of POMALYST marks another important milestone for Canadian patients and brings us one step closer to transforming multiple myeloma into a long-term, manageable disease."

An oral immunomodulatory drug, POMALYST will be distributed through an existing controlled distribution programme called RevAid.

RevAid is a risk management programme developed in 2008, designed to prevent fetal exposure to POMALYST due to its structural similarities to thalidomide, a known human teratogen.

Image: Micrograph of a plasmacytoma, the histologic correlate of multiple myeloma. Photo: courtesy of Nephron.