Thursday, October 23, 2008

NEW ORAL THERAPY FOR blood cancer approved in Canada

Unprecedented Overall Survival Data for Revlimid® gives Renewed Hope to Multiple Myeloma
Patients with Advanced Disease

OAKVILLE, ON – (October 6, 2008) – Health Canada has approved Revlimid® (lenalidomide), a new treatment with proven ability to increase overall survival and slow disease progression, in combination with dexamethasone, for the treatment of multiple myeloma patients who have received at least one therapy. Prior to approval, there were few effective, once-daily oral treatment options available for patients with this aggressive blood cancer.

"The clinical data shows that patients treated with Revlimid and dexamethasone have superior response rates and for a longer duration, experience slower progression of disease, and survive longer than we have ever seen before,” said Dr. Darrell White, Hematologist, Nova Scotia Cancer Centre, Dalhousie University. “This Health Canada approval means that we can now treat many more patients with this incurable form of cancer.”

Multiple myeloma (MM) is a rare, progressive and fatal blood cancer with significant morbidity and mortality[i]. Incidence increases with age and median age at diagnosis is between 63 and 70 years of age. Of the estimated 6000 Canadians suffering with the disease, approximately 1000 will die this year and 2000 new patients will be diagnosed at treatment centres across Canada.

“There is no cure for multiple myeloma, but new oral cancer therapies, like Revlimid, are a step towards changing multiple myeloma into a manageable chronic disease and thus improving patient quality of life,” said Dr. White.

“Revlimid, a once-daily pill, is the only treatment that was able to control my cancer after many attempts, including bone marrow transplants,” said Derek Hunter, a multiple myeloma patient from Saint John, New Brunswick who was diagnosed in 2003. “My greatest hope is that other patients will be given the same chance at life by having access to this great treatment.”

The Health Canada approval was based on the results of two Phase III clinical trials, published in the New England Journal of Medicine, evaluating Revlimid with dexamethasone in previously treated multiple myeloma patients which showed an increased overall survival rate and slowed disease progression[ii]. Revlimid will be available in 15 mg and 25 mg oral capsules for the treatment of multiple myeloma after one prior therapy.


REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of hematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of-matter and use patents.
About Multiple Myeloma
Multiple myeloma is the second most common blood cancer and represents approximately 1% of all cancers and 2% of all cancer deaths. The Canadian Cancer Society reports that there are about 6000 Canadians living with multiple myeloma, and approximately 2000 new cases are diagnosed each year.[iii]

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.

About Celgene

Celgene Corporation is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at Revlimid is a registered trademark of Celgene Corporation.

Revlimid® was granted the Prix Galien USA 2008 Award for Special Therapeutic Development on September 24, 2008. The Prix Galien Award recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and is considered to be the highest accolade for pharmaceutical research and development.

[i] Canadian Cancer Society/National Cancer Institute of Canada. Canadian Cancer Statistics 2008. Accessed October 1, 2008 at
[ii] New England Journal of Medicine, November 22, 2007
[iii] Canadian Cancer Society. Canadian Cancer Statistics 2008.

Media Contacts:
Tara Knight / Celeste Brown
Hill & Knowlton Canada
(416) 413-4774 / (416) 413-4651 /
MYELOMA CANADA ENDORSES HEALTH CANADA’S APPROVAL OF REVLIMID Revlimid signals new hope for Canadians with bone marrow cancer
Today marked a major step forward for the Canadian myeloma community with Health Canada’s approval of Revlimid in combination with dexamethasone for the treatment of multiple myeloma patients with relapsed or refractory disease.Myeloma Canada issued the following press release endorsing this long-anticipated decision by Health Canada. Attached is the press release issued by Celgene, the manufacturer of Revlimid.Myeloma Canada will continue to monitor further developments as Revlimid makes it way through the Joint Oncology Drug Review (JODR) process. For information on JODR, please click on the following link:

MONTREAL, QC – (October 6, 2008) – Myeloma Canada endorses Health Canada’s decision to approve Revlimid® (lenalidomide), a new treatment for multiple myeloma, clearly demonstrating their commitment to fighting this incurable form of cancer. Revlimid is an oral medication that has demonstrated an ability to extend overall survival of multiple myeloma patients and slow the progression of the disease for patients who have failed other treatments.

“Health Canada’s approval of Revlimid is welcome news for Canadians living with multiple myeloma,” says Myeloma Canada President John Lemieux. “Scientific advances in treatments of blood disorders are helping patients live much longer and have a better quality of life. We are extremely pleased to hear about this approval as it supports doctors in providing the best possible care to all patients.”

About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. The cancer starts in plasma cells, which are made in the bone marrow, and develop into antibodies that help fight infections. In myeloma, abnormal plasma cells, called myeloma cells, grow uncontrollably, crowding out the normal blood cells in the bone. This can bring symptoms such as fatigue, recurrent infections and pain resulting from bone fractures, which disturb the body’s balance of minerals and prevent other organs, such as the kidney and nerves, from working properly. In Canada, approximately 2,000 people are diagnosed with multiple myeloma every year.
Myeloma Canada
Myeloma Canada is a non-profit organization, with registered charity status dedicated to supporting people living with multiple myeloma and is the only national organization exclusively devoted to the Canadian myeloma community. The mission of Myeloma Canada is to: provide educational resources and support to patients, families, and caregivers; increase awareness of the disease; and promote improved access to new therapies, treatment options, and health care resources. Myeloma Canada works with regional support groups and key myeloma experts to strengthen the voice of the Canadian myeloma community. Myeloma Canada works in close affiliation with the International Myeloma Foundation, the world’s oldest and largest myeloma organization. For more information or to find out how you can help please visit our website at
Canada / Myélome Canada
Uniquely devoted to Canada's myeloma communityExclusivement au service de la communauté canadienne du myélome
Mailing Address/Adresse postale:
PO Box / CP 326
Kirkland, QC,
H9H 0A4
(514) 570-9769

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