SUMMIT, NJ, March 23 /CNW/ - Celgene Corporation (Nasdaq: CELG) announced
today that its innovative oral cancer drug REVLIMID (lenalidomide) has
received a positive opinion from the European Medicines Agency (EMEA) for use
in combination with dexamethasone as a treatment for patients with multiple
myeloma who have received at least one prior therapy. The EMEA's Committee for
Medicinal Products for Human Use (CHMP), which reviews applications for all 27
Member States in the European Union (EU) as well as Norway and Iceland, has
recommended approval for REVLIMID. The CHMP's positive opinion will be
forwarded to the European Commission that generally follows the recommendation
of the CHMP and issues final marketing approval within two to three months.
Multiple myeloma is the second most commonly diagnosed blood cancer.
According to the International Myeloma Foundation, there are an estimated
750,000 people with MM worldwide. There are more than 85,000 men and women in
Europe undergoing treatment for multiple myeloma, and 25,000 people are
expected to die from this blood cancer in 2007.
"The CHMP recommendation is an especially important and positive
milestone for Celgene. We are fully committed to deliver REVLIMID to patients
in need throughout the EU," said Aart Brouwer, President of Celgene
International. "We're optimistic that REVLIMID will have broad support based
on its value to patients and to the healthcare system. Upon approval we are
prepared to initiate next steps for pricing, reimbursement and distribution
plans for all EU member states."
The positive opinion from the CHMP was based upon the safety and efficacy
results of two large, randomized pivotal Phase III special protocol assessment
trials, North American Trial MM-009 and International Trial MM-010, evaluating
REVLIMID plus dexamethasone in multiple myeloma patients that have received at
least one prior therapy.
"The positive opinion of REVLIMID from the CHMP is an important step
forward towards providing a new oral therapeutic option for this particular
group of patients with multiple myeloma," said Graham Burton, M.D., SVP,
Global Regulatory Affairs and Pharmacovigilance for Celgene. "We are committed
to continue our work with the European authorities to bring REVLIMID to
patients in need as quickly as possible."
Upon the European Commission's approval for REVLIMID as an oral
combination treatment with dexamethasone for multiple myeloma patients who
have received at least one prior therapy, Celgene Europe will initiate next
steps for marketing, distribution, pricing and reimbursement approvals for all
EU member states.
REVLIMID has obtained Orphan Drug designation in the EU, US and Australia
for treatment of Multiple Myeloma and is already approved for use as a
treatment in combination with dexamethasone for patients previously treated
with multiple myeloma by the U.S. Food and Drug Administration (FDA). REVLIMID
is also approved 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 by the FDA.
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
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 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%).
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 75 clinical trials in a broad range of oncological
conditions, both in blood cancers and solid tumors. The IMiDs pipeline is
covered by a comprehensive intellectual property estate of U.S. and foreign
issued and pending patent applications including composition-of- matter and
About Multiple Myeloma
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.
FOR FURTHER INFORMATION ABOUT REVLIMID AND RevAssist, A RESTRICTED
DISTRIBUTION PROGRAM USED IN THE UNITED STATES, YOU MAY GO TO THE INTERNET AT
www.REVLIMID.com OR BY CALLING THE MANUFACTURER'S TOLL FREE NUMBER 1-888-
4CELGENE. RevAssist is a proprietary risk-management restrictive distribution
program, tailored specifically for REVLIMID patients, to prevent the potential
for human birth defects and ensure prompt and convenient access to REVLIMID
through contracted pharmacies.
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical 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
REVLIMID(R) and RevAssist(R) are registered trademarks of Celgene
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.
For further information:
For further information: David W. Gryska, Sr. Vice President and Chief
Financial Officer, +1-908-673-9059, or Brian P. Gill, Vice President,
Corporate Communications, +1-908-673-9530, both of Celgene Corporation, Web