SUMMIT, N.J., Oct. 4 /PRNewswire-FirstCall/ -- The New England Journal of Medicine today published final results of a Celgene Corporation 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 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 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 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.
Celgene CorporationCONTACT: Robert J. Hugin, President & COO, +1-908-673-9102, or Brian P.Gill, Senior Director of PR & IR, +1-908-673-9530, both of CelgeneCorporation
