SUMMIT, N.J., Oct. 4 /PRNewswire-FirstCall/ -- The New England Journal
of Medicine today published final results of a Celgene Corporation (Nasdaq:
CELG) sponsored Phase II trial evaluating REVLIMID(R) (lenalidomide) as an
oral therapy for patients with myelodysplastic syndromes (MDS) with
transfusion- dependent anemia and deletion 5q cytogenetic abnormality with
or without additional cytogenetic abnormalities. MDS is a malignant
disorder of blood cell production that affects approximately 300,000 people
worldwide. The most common clinical manifestation associated with MDS is
refractory anemia, and the multiple complications that stem from frequent
blood transfusions.
REVLIMID is indicated for use as a treatment in combination with
dexamethasone for multiple myeloma patients who have received at least one
prior therapy. REVLIMID is also indicated for treatment of 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.
"The recent clinical data from this Phase II study evaluating REVLIMID
as an oral MDS treatment not only demonstrates hematologic response, but
this is the first MDS treatment to demonstrate this level of cytogenetic
response." said Dr. Alan List, Professor of Oncology and Medicine, and
Chief, Malignant Hematology Division at the H. Lee Moffitt Cancer Center,
Tampa, Florida, and the study's lead investigator.
SAFETY NOTICE:
WARNINGS:
1. POTENTIAL FOR HUMAN BIRTH DEFECTS.
LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN
HUMAN TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH
DEFECTS. IF LENALIDOMIDE IS TAKEN DURING PREGNANCY, IT MAY CAUSE BIRTH
DEFECTS OR DEATH TO AN UNBORN BABY. FEMALES SHOULD BE ADVISED TO AVOID
PREGNANCY WHILE TAKING REVLIMID(R) (lenalidomide).
Special Prescribing Requirements
BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL EXPOSURE TO
REVLIMID (lenalidomide), REVLIMID(R) (lenalidomide) IS ONLY AVAILABLE
UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM. THIS PROGRAM IS CALLED
"RevAssist(R)". UNDER THIS PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS
REGISTERED WITH THE PROGRAM ARE ABLE TO PRESCRIBE AND DISPENSE THE
PRODUCT. IN ADDITION, REVLIMID (lenalidomide) MUST ONLY BE DISPENSED TO
PATIENTS WHO ARE REGISTERED AND MEET ALL THE CONDITIONS OF THE
RevAssist PROGRAM.
2. HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA).
THIS DRUG IS ASSOCIATED WITH SIGNIFICANT NEUTROPENIA AND
THROMBOCYTOPENIA IN PATIENTS WITH DELETION 5q MDS. EIGHTY PERCENT OF
PATIENTS HAD TO HAVE A DOSE DELAY/REDUCTION DURING THE MAJOR STUDY FOR
THE DELETION 5q MDS INDICATION. THIRTY-FOUR PERCENT OF PATIENTS HAD TO
HAVE A SECOND DOSE DELAY/REDUCTION. GRADE 3 OR 4 HEMATOLOGIC TOXICITY
WAS SEEN IN 80% OF PATIENTS ENROLLED IN THE STUDY. PATIENTS ON THERAPY
FOR DELETION 5q MDS SHOULD HAVE THEIR COMPLETE BLOOD COUNTS MONITORED
WEEKLY FOR THE FIRST 8 WEEKS OF THERAPY AND AT LEAST MONTHLY
THEREAFTER. PATIENTS MAY REQUIRE DOSE INTERRUPTION AND/OR REDUCTION.
PATIENTS MAY REQUIRE USE OF BLOOD PRODUCT SUPPORT AND/OR GROWTH
FACTORS. (SEE DOSAGE AND ADMINISTRATION)
3. DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM.
This drug has demonstrated a significantly increased risk of deep
venous thrombosis (DVT) and pulmonary embolism (PE) in patients with
multiple myeloma who were treated with REVLIMID(R) (lenalidomide)
combination therapy. Patients and physicians are advised to be
observant for the signs and symptoms of thromboembolism. Patients
should be instructed to seek medical care if they develop symptoms such
as shortness of breath, chest pain, or arm or leg swelling. It is not
known whether prophylactic anticoagulation or antiplatelet therapy
prescribed in conjunction with REVLIMID (lenalidomide) may lessen the
potential for venous thromboembolic events. The decision to take
prophylactic measures should be done carefully after an assessment of
an individual patient's underlying risk factors.
You can get information about REVLIMID(R) (lenalidomide) and the
RevAssist program on the Internet at http://www.REVLIMID.com or by calling the
manufacturer's toll-free number at 1-888-423-5436.
IMPORTANT SAFETY INFORMATION
Hypersensitivity: REVLIMID (lenalidomide) is contraindicated in any
patients who have demonstrated hypersensitivity to the drug or its
components.
Renal impairment: REVLIMID (lenalidomide) is substantially excreted by
the kidney, so the risk of toxic reactions may be greater in patients with
impaired renal function. Because elderly patients are more likely to have
decreased renal function, care should be taken in dose selection, and it
would be prudent to monitor renal function.
Nursing mothers: It is not known whether REVLIMID (lenalidomide) is
excreted in human milk. Because of the potential for adverse reactions in
nursing infants, a decision should be made whether to discontinue nursing
or the drug, taking into account the importance of the drug to the mother.
Other adverse events Multiple Myeloma (REVLIMID/dexamethasone):
constipation (39%), fatigue (38%), insomnia (32%), muscle cramp (30%),
diarrhea (29%), neutropenia (28%), anemia (24%), asthenia (23%), pyrexia
(23%), nausea (22%), headache ((21%), peripheal edema (21%), dizziness
(21%), dyspnea (20%), tremor (20%), decreased weight (18%),
thrombocytopenia (17%), rash (16%), back pain (15%), hyperglycemia (15%),
and muscle weakness (15%).
Deletion 5q MDS (REVLIMID(R)): diarrhea (49%), pruritus (42%), rash
(36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngitis
(23%), arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema
(20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%),
dyspnea (17%), and pharyngitis (16%).
About REVLIMID(R)
REVLIMID is a member of a proprietary group of novel immunomodulatory
agents. Celgene continues to evaluate REVLIMID in a broad range of
hematology and oncology conditions. The IMiDs(R) pipeline, including
REVLIMID, is covered by a comprehensive intellectual property estate of
U.S. and foreign issued and pending patent applications including
composition-of-matter and use patents.
About RevAssist(R)
FOR FURTHER INFORMATION ABOUT REVLIMID AND THE RevAssist PROGRAM, YOU
MAY GO TO THE INTERNET AT http://www.REVLIMID.com OR BY CALLING THE MANUFACTURER'S
TOLL FREE NUMBER 1-888-423-5436 RevAssist is a proprietary risk-management,
restricted distribution program, tailored specifically for REVLIMID
patients, to prevent the potential for human birth defects
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematopoietic stem cell
malignancies that affect approximately 300,000 people worldwide. As a
result, blood cells remain in an immature or sometimes "blast" stage within
the bone marrow and never develops into mature cells capable of performing
their necessary functions. Eventually, the bone marrow may be filled with
blast cells suppressing normal cell development. According to the American
Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year
in the United States, with mean survival rates ranging from approximately
six months to six years for the different classifications of MDS. MDS
patients must often rely on blood transfusions to manage symptoms of anemia
and fatigue and may develop life-threatening iron overload and/or toxicity
from frequent transfusions, thus underscoring the critical need for new
therapies targeting the cause of the condition rather than simply managing
its symptoms.
About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half
of patients with myelodysplastic syndrome (MDS), and commonly involve a
deletion in all or part of one or more specific chromosomes. The most
common cytogenetic abnormalities in MDS are deletions involving 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 percent to 30 percent of all MDS patients with chromosome
abnormalities. The World Health Organization has also recently identified a
distinct subset of MDS patients with a "5q- Syndrome" where the only
chromosomal abnormality is a specific portion of the 5q chromosome and the
patients have a clinical presentation including macrocytosis, severe
anemia, normal to elevated platelets, hypolobulated megakaryocytes, and low
marrow blast percentage.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through gene and protein
regulation. For more information, please visit the Company's website at
http://www.celgene.com .
REVLIMID(R) and RevAssist(R) are registered trademarks of Celgene
Corporation.
This release contains forward-looking statements which are subject to
known and unknown risks, delays, uncertainties and other factors not under
the Company's control, which may cause actual results, performance or
achievements of the Company to be materially different from the results,
performance or other expectations expressed or implied by these
forward-looking statements. These factors include results of current or
pending research and development activities, actions by the FDA and other
regulatory authorities, and other factors described in the Company's
filings with the Securities and Exchange Commission such as our 10K, 10Q
and 8K reports.
SOURCE Celgene Corporation
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Related links:
http://www.celgene.com
http://www.REVLIMID.com
CONTACT:
Robert J. Hugin, President & COO,
+1-908-673-9102, or Brian P. Gill, Senior Director of PR & IR,
+1-908-673-9530, both of Celgene Corporation
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