New Oral Medication Gives Hope to Patients with Blood Cancer

[Doug Mylie]

Health Canada has granted a Notice of Compliance with Conditions (NOC/c) to the oral cancer therapy REVLIMID(R) (lenalidomide) to treat patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

In clinical trials, Revlimid has been shown to significantly reduce or eliminate the need for blood transfusions and raise hemoglobin to nearly normal levels in the majority of these patients."Revlimid is a great advance for the teatment of patients withthis particular type of MDS," said Dr. Richard Wells, Co-Director of the Crashley Myelodysplastic Syndrome Research Program,Sunnybrook Research Institute. "Our clinic has seen dramatic life-transforming results. Patients treated with Revlimid may stop needing blood transfusions which means they feel healthier and energized. Also, Revlimid allows patients to enjoy more independence and have fewer hospital visits." Unlike other treatments for deletion 5q MDS, Revlimid treats the underlying cause of the disease rather than merely the symptoms.

Prior to Revlimid, patients relied on blood transfusions to manage symptoms of anemia and fatigue caused by low red blood cell counts. Revlimid not only stimulates the production of red blood cells but also suppresses abnormal cells in the bone marrow, thus enabling the proliferation of healthy cells. These effects can improve anemia, and reduce or eliminate the need for transfusions, which are associated with significant clinical complications such as life-threatening iron overload and toxicity.(1),(2) In clinical trials, 67 per cent of deletion 5q MDS patients treated with Revlimid did not need a blood transfusion.(3) "Revlimid has given me my life back," said Jean Hardy, a deletion 5q MDS patient. "I was diagnosed with deletion 5q MDS a year and a half ago and developed severe anemia which left me so tired I could barely function. Revlimid, a simple pill, worked better than blood transfusions to build up my strength. Now, it's as if I don't even have a disease. My greatest hope is that other people with this disease be given the same chance at life I've received by having access to this great treatment."

Mean survival rates can range from approximately six months to six years for people with different classifications of MDS. For roughly 30 per cent of patients diagnosed with this disorder, the abnormal bone marrow cells eventually progress into acute myeloid leukemia (AML), a rapidly growing cancer of the bone marrow cells.(4),(5)

"Health Canada's approval of Revlimid is welcome news for Canadian patients living with this type of blood cancer," said Gord Sanford, President, Aplastic Anemia and Myelodysplasia Association of Canada (AAMAC). "Scientific advances in treatments of blood disorders are helping patients live longer and have a better quality of life. It is our hope that patients will soon have access to this important treatment advance."

RevAid(SM) Program Celgene has implemented a restricted distribution program called RevAid.

The risk management program was developed to prevent fetal exposure to the drug, due to its structural similarities to thalidomide, a known human teratogen. Under the program, only prescribers and pharmacists registered with RevAid are able to prescribe and dispense Revlimid. In addition, only those patients who are registered and meet all the conditions of the RevAid program will receive Revlimid. Celgene expects Revlimid to be available to Canadian patients through RevAid in February 2008.

There are an estimated 6,000 Canadians living with MDS and approximately 1,500 new MDS cases diagnosed each year.

Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome (MDS), and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5,7, and 20. Another common abnormality is an extra copy of chromosome 8. Adeletion involving the 5q chromosome may be involved in 20 per cent to 30 percent of all MDS patients.

Revlimid is an IMiDs(R) 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.

For more information, please visit the Company's website at www.celgene.com.

Revlimid is a registered trademark of Celgene Corporation. RevAid is a service mark of Celgene.