Clinical Data From REVLIMID(R) Study in Myelodysplastic Syndromes Reported in New England Journal of Medicine

Oct 04, 2006, 01:00 ET from Celgene Corporation

    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 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.
 
 

SOURCE Celgene Corporation
    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 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.
 
 SOURCE Celgene Corporation