Pomalyst is now approved in Canada for the treatment of certain patients with multiple myeloma.

Specifically, Health Canada approved Pomalyst ^[1] (pomalidomide, Imnovid) for use in combination with dex­a­meth­a­sone ^[2] (Decadron) in patients with multiple myeloma for whom both Revlimid ^[3] (lenalidomide) and Velcade ^[4] (bor­tezomib) have failed, who have received at least two prior treatment regimens, and who have demon­strat­ed disease progression on their last therapy.

Health Canada approved Pomalyst on January 20, but the approval was first announced this morning.

Celgene (NASDAQ: CELG), the company that developed and markets Pomalyst, expects Pomalyst to be commercially available in Canada next month.

Health Canada is the third regulatory authority globally to approve Pomalyst.  Both the U.S. Food and Drug Administration and the European Commission approved the use of Pomalyst for myeloma last year (see related Beacon news about the United States ^[5] and Europe ^[6]).

Prior to Pomalyst, the last Canadian approval of a novel myeloma therapy was in February 2011, when Health Canada approved thalidomide ^[7] (Thalomid) as a treatment for myeloma.  Thalidomide had been im­ported regularly into Canada to treat myeloma patients, however, prior to Health Canada's official approval of the drug.

Kyprolis ^[8] (carfilzomib), another novel mye­loma therapy, was approved for use in the U.S. in July 2012 (see related Beacon ^[9] news).  Kyprolis is not yet approved in any other country.

Pomalyst is chemically similar to Revlimid and thalidomide.  All three drugs are administered orally as a capsule or tablet, and the three drugs together make up the class of myeloma therapies known as immu­no­mod­ulatory agents. Celgene also markets Revlimid and thalidomide.

Celgene has not yet said publicly what the price of Pomalyst will be in Canada.  The current cost of a 28-day cycle of Pomalyst is $10,750 in the U.S. and approximately $13,000 in Europe, based on a 21-out-of-28-day dosing regimen, and using November 2013 data for the European market from the IHS POLI database.

When asked to comment on Pomalyst’s Canadian approval, Dr. Rodger Tiedemann of the Princess Margaret Cancer Centre and University of Toronto told The Beacon, “The approval of Pomalyst is welcome news for the myeloma community in Canada.”

“Pomalyst is the third in a series of immunomodulatory drugs to be approved for the treatment of multiple myeloma and is the most potent drug in its class. Like all of the immunomodulatory drugs, Pomalyst is oral and is particularly well tolerated,” explained Dr. Tiedemann. “It represents an important addition to the grow­ing arsenal of drugs available for the treatment of multiple myeloma. Its principal significance at present is that it can be effective in some patients that are double refractory to both Velcade and Revlimid.”

Nancy Shamanna, a Canadian resident diagnosed with multiple myeloma and a columnist for The Beacon, was ecstatic to hear the news of Pomalyst’s approval in Canada.  She told The Beacon, “Since myeloma is a disease that unfortunately tends towards relapse, one never knows when one may need medical treatment, even if one has done well so far, as I have.  From what I know of Pomalyst, it is another excellent novel agent.  I know that it will help many patients here, and I am overwhelmed with gratitude that we may soon have it available.”

She further explained, “Since health care is in the realm of the Canadian provinces, each province will have to approve the use of the drug individually.”

The Canadian approval of Pomalyst is based on data from the Phase 3 “MM-003” clinical trial in relapsed and refractory myeloma patients. The study included 455 heavily pretreated myeloma patients and com­pared treatment with Pomalyst plus low-dose dex­a­meth­a­sone to treatment with high-dose dex­a­meth­a­sone alone.

Patients in the Pomalyst and low-dose dex­a­meth­a­sone arm of the MM-003 trial experienced a statistically longer progression-free survival (a median of 4.0 months) com­pared to the patients in the high-dose dex­a­meth­a­sone arm (1.9 months).

The median overall survival was also significantly longer for patients treated with Pomalyst (12.7) com­pared to those treated with dex­a­meth­a­sone alone (8.1 months).

Results from the MM-003 trial were published in October 2013 (see related Beacon ^[10] news), and additional analyses of the study were presented at the American Society of Hematology meeting in December 2013 (see related Beacon ^[11] news).

In Pomalyst’s clinical trials, the most frequent serious side effects were low red blood cell, white blood cell, and platelet counts, as well as infections such as pneumonia.

Until Pomalyst is available in Canada, patients who qualify can receive Pomalyst through an expanded access clinical trial called PEXIUS ^[12], which is being conducted at several centers in Canada.

For more information about today’s Health Canada approval of Pomalyst, please see the Celgene ^[13] press release.