REVLIMID(R) receives reimbursement green light from the Ontario
Government for the treatment of deletion 5q myelodysplastic syndrome
OAKVILLE, ON, April 22 /CNW/ - Patients in Ontario with a serious blood
disorder called deletion 5q myelodysplastic syndrome (del5q MDS) now have
access to the latest treatment advance which, for the first time, treats the
underlying cause of the disease and provides patients with an improved quality
The Ontario government has announced their decision to reimburse the
innovative oral therapy REVLIMID (lenalidomide) through the province's
Exceptional Access Program.
"REVLIMID acts quickly and provides long-lasting responses in patients,
enhancing their quality of life," said Dr. Richard Wells, Director of the
Crashley Myelodysplastic Syndrome Laboratory at Sunnybrook's Odette Cancer
Centre in Toronto. "Patients who don't have access to REVLIMID have to rely on
regular blood transfusions to manage symptoms of anemia and fatigue caused by
low red blood cell counts. Rather than requiring transfusions, patients have
the convenient option of taking an oral medication at home, ending the cycle
of fatigue and decline caused by transfusions and restoring their quality of
Unlike other treatments for del5q MDS, REVLIMID treats the underlying
cause of the disease, rather than merely the symptoms, by affecting changes at
the genetic level. REVLIMID suppresses abnormal cells in the bone marrow to
enable the proliferation of healthy new cells. It can provide durable
responses in patients who experience severe chronic anemia and help eliminate
the need for frequent blood cell transfusions which carry the risk of
significant clinical complications such as life-threatening iron overload and
toxicity. In clinical trials, 67 per cent of del 5q MDS patients treated with
REVLIMID no longer required blood transfusions.
"This is tremendous news for patients in Ontario with this form of MDS,"
said Stan Chmelyk, President, Aplastic Anemia and Myelodysplasia Association
of Canada (AAMAC). "This new oral option will revolutionize MDS treatment and
simplify life for patients by helping to reduce their need for blood
transfusions. It is our hope this important new therapy is made available in
all provinces as soon as possible for the patients who can benefit from it."
The Ontario government decision to reimburse REVLIMID for del5q MDS
followed a review by the Joint Oncology Drug Review Process (JODR). British
Columbia became the first province to fund REVLIMID for the treatment of del5q
MDS earlier in 2008.
Health Canada granted a Notice of Compliance with Conditions (NOC/c) to
REVLIMID (lenalidomide) in January 2008 for the treatment of
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.
The NOC/c is based upon the safety and efficacy results of a Phase II
clinical trial (MDS-003), evaluating REVLIMID(R) in patients with
transfusion-dependent anemia due to Low- or Intermediate-1-risk MDS associated
with a deletion 5q cytogenetic abnormality with or without additional
Celgene, the manufacturer of REVLIMID, hopes that the listings in Ontario
and British Columbia lead all governments to quickly follow suit in providing
access to this important new therapy.
About MDS, Deletion 5q Chromosomal Abnormality, and Survival
MDS is a group of similar blood disorders that occur when blood cells in
the bone marrow do not mature and eventually suppress normal cell development.
There are an estimated 6,000 Canadians living with MDS and approximately 1,500
new MDS cases diagnosed each year. A deletion involving the 5q chromosome in
patients with MDS may be involved in approximately 20 percent of all MDS
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.
REVLIMID is an IMiDs(R) compound, a member of a proprietary group of
novel immunomodulatory agents. REVLIMID and other IMiD compounds continue to
be evaluated in over 100 clinical trials in a broad range of hematological and
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 www.celgene.com.
REVLIMID is a registered trademark of Celgene Corporation.
Note to Editors:
NOC/c - A Notice of Compliance with Conditions allows for early market
access of promising new drugs for diseases that are serious or life
threatening, where the new drug appears to provide benefit over available
therapy, or where no therapy currently exists.
For further information:
For further information: FOR MEDIA INTERVIEWS, PLEASE CONTACT: Rosalind
O'Connell, Hill and Knowlton Canada, (416) 413-4773,