REVLIMID(R) Receives Health Canada Approval for the Treatment of
Deletion 5q Myelodysplastic Syndromes
OAKVILLE, ON, Jan. 24 /CNW/ - Celgene announced today that 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 treatment of patients with this
particular type of MDS," said Dr. Richard Wells, Co-Director of the Crashley
Myelodysplastic Syndrome Research Program, Odette Cancer Centre and Scientist
with the 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
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
"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."
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.
About MDS and Deletion 5q Chromosomal Abnormality
MDS are a group of similar blood cancers 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.
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. A deletion
involving the 5q chromosome may be involved in 20 per cent to 30 per cent 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
The NOC/c is based upon the safety and efficacy results of a Phase II
clinical trial (MDS-003)(6), evaluating Revlimid 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
cytogenetic abnormalities. The trial showed that 76 per cent of the patients
who were given Revlimid needed fewer transfusions than before entering the
study, and 67 per cent became transfusion-independent, with a rise in
hemoglobin to a nearly normal range. The response to treatment was rapid and
durable with 90 per cent of those achieving transfusion independence doing so
within three months; 62 per cent who had a response to treatment remained
transfusion-free for at least one year, and the median duration of transfusion
independence had not been reached after a median follow-up of two years.
Currently, the median time of transfusion independence is 104 weeks.
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. RevAid is a
service mark of Celgene.
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.
(1) Thomas ML. Strategies for achieving transfusion independence in
myelodysplastic syndromes. Eur J Oncol Nursing 2007;11:151-158.
(2) Nimer SD. Clinical management of myelodysplastic syndromes with
interstitial deletion of chromosome 5q. J Clin Oncol 2006;24:2576-
(3) Revlimid(R) Product Monograph. Celgene Corporation (2008).
(4) American Cancer Society. Myelodysplastic syndromes and
myelodysplastic/ myeloproliferative diseases. Available at
(5) Kouides, P.A. and Bennet, J.M. (2007). Understanding Myelodysplastic
Syndromes: A Patient Handbook. The Myelodysplastic Syndromes
Foundation, Inc. Available at
(6) List, A., Dewald G., Bennett, J., et al. Lenalidomide in the
Myelodysplastic Syndrome with Chromosome 5q Deletion, NEJM,
Vol 355:1456-1465, Oct. 5, 2006 Number 14
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