SUMMIT, N.J., September 4 /CNW/ - Celgene International Sarl (NASDAQ:
CELG) announced today that it's oral cancer drug, REVLIMID (lenalidomide) has
been granted approval by the Swiss Agency for Therapeutic Products
(Swissmedic) for use in combination with dexamethasone as a treatment for
patients with multiple myeloma who have received at least one prior therapy.
This approval represents the first regulatory approval for Celgene in
Switzerland, and REVLIMID represents the first oral therapy in Switzerland for
multiple myeloma patients in more than forty years. REVLIMID is currently
approved by the U.S. Food and Drug Administration (FDA) under 21 CFR 314.500,
Acclerated Approval of New Drugs for Serious or Life-Threatening Illnesses.
Multiple myeloma is the second most commonly diagnosed blood cancer.
According to the International Myeloma Foundation, there are an estimated
750,000 people with multiple myeloma worldwide. There are more than 85,000 men
and women in Europe currently undergoing treatment for multiple myeloma, and
25,000 people are expected to die from this blood cancer in 2007.
Celgene International is working diligently with Swissmedic to determine
next steps for pricing, reimbursement and distribution so that REVLIMID is
available for eligible patients in Switzerland as quickly as possible.
The Marketing Authorization Application (MAA) for REVLIMID 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.
Celgene remains committed to the broad and global clinical development of
other investigational therapies being studied in blood and solid tumor
REVLIMID has obtained Orphan Drug designation in the EU, US and Australia
for treatment of multiple myeloma. REVLIMID is approved for use as an oral
treatment in combination with dexamethasone by the European Commission,
following the recommendation from the European Medicines Agency (EMEA).
REVLIMID is currently approved in the US by the U.S. Food and Drug
Administration (FDA) for multiple myeloma patients who have received at least
one prior therapy. REVLIMID is also approved in the US, 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 and subject
to a restricted distribution program named RevAssist(R).
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
Special Prescribing Requirements
BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL EXPOSURE TO
REVLIMID(R) (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 CAN PRESCRIBE AND DISPENSE THE PRODUCT. IN
ADDITION, REVLIMID(R) (lenalidomide) MUST ONLY BE DISPENSED TO PATIENTS WHO
ARE REGISTERED AND MEET ALL THE CONDITIONS OF THE RevAssist(R) PROGRAM.
2. HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA).
THIS DRUG IS ASSOCIATED WITH SIGNIFICANT NEUTROPENIA AND
THROMBOCYTOPENIA. EIGHTY PERCENT OF PATIENTS WITH DEL 5q MYELODYSPLASTIC
SYNDROMES HAD TO HAVE A DOSE DELAY/REDUCTION DURING THE MAJOR STUDY.
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 DEL 5q MYELODYSPLASTIC SYNDROMES 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(R) (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 the information about REVLIMID(R) (lenalidomide) and the
RevAssist(R) program on the Internet at www.REVLIMID.com or by calling the
manufacturer's toll-free number at 1-888-423-5436.
ADDITIONAL WARNINGS: HEMATOLOGIC TOXICITY
In the pooled multiple myeloma studies, Grade 3 and 4 hematologic
toxicities were more frequent in patients treated with the combination of
REVLIMID(R) (lenalidomide) and dexamethasone than in patients treated with
dexamethasone alone. Patients on therapy should have their complete blood
counts monitored every 2 weeks for the first 12 weeks and then monthly
thereafter. Patients may require dose interruption and/or dose reduction.
Hypersensitivity: REVLIMID(R) (lenalidomide) is contraindicated in any
patients who have demonstrated hypersensitivity to the drug or its components.
Renal impairment: REVLIMID(R) (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(R) (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.
In the REVLIMID(R) (lenalidomide)/dexamethasone treatment group, 151
patients (45%) underwent at least one dose interruption with or without a dose
reduction of REVLIMID(R) (lenalidomide) compared to 21% in the
placebo/dexamethasone treatment group. Of these patients who had one dose
interruption with or without a dose reduction, 50% in the REVLIMID(R)
(lenalidomide)/dexamethasone treatment group underwent at least one additional
dose interruption with or without a dose reduction compared to 21% in the
placebo/dexamethasone treatment group.
Other adverse events reported in multiple myeloma patients (REVLIMID(R)
(lenalidomide)/dexamethasone vs dexamethasone/placebo): constipation (39% vs
19%), fatigue (38% vs 37%), insomnia (32% vs 37%), muscle cramp (30% vs 21%),
diarrhea (29% vs 25%), neutropenia (28% vs 5%), anemia (24% vs 17%), asthenia
(23% vs 25%), pyrexia (23% vs 19%), nausea (22% vs 19%), headache (21% vs
21%), peripheral edema (21% vs 19%), dizziness (21% vs 15%), dyspnea (20% vs
15%), tremor (20% vs 7%), decreased weight (18% vs 14%), thrombocytopenia (17%
vs 10%), rash (16% vs 8%), back pain (15% vs 14%), hyperglycemia (15% vs 14%),
and muscle weakness (15% vs 15%).
Other adverse reactions reported in del 5q MDS patients (REVLIMID(R)
(lenalidomide)): 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
DOSAGE AND ADMINISTRATION:
Dosing is continued or modified based upon clinical and laboratory
findings. Dosing modifications are recommended to manage Grade 3 or 4
neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be
related to lenalidomide. For other Grade 3 or 4 toxicities judged to be
related to lenalidomide, hold treatment and restart at next lower dose level
when toxicity has resolved to less than or equal to Grade 2.
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 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.
Swissmedic is the central Swiss supervisory authority for therapeutic
products. To protect humans and animals, Swissmedic ensures that only
high-quality, safe and effective medicines and medical devices are placed on
the market in Switzerland. Swissmedic is a public service organization of the
federal government with headquarters in Bern. It is independent in its
organization and management and has its own separate budget. Swissmedic is
linked to the Federal Department of Home Affairs (FDHA). The Agency Council is
its highest body and represents Swissmedic in contacts with the FDHA and the
Federal Council (the Swiss government). It also approves Swissmedic's annual
budget, annual accounts, and annual report.
Celgene Corporation, headquartered in Summit, New Jersey, 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
REVLIMID(R) and RevAssist(R) are registered trademarks of Celgene
This release contains certain forward-looking statements which involve
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 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 those factors
detailed in the Company's filings with the Securities and Exchange Commission
such as Form 10-K, 10-Q and 8-K reports.
For further information:
For further information: Celgene Corporation David Gryska Sr. Vice
President and Chief Financial Officer 908-673-9059 or Brian P. Gill Vice
President, Global Corporate Communications 908-673-9530