Healthcare Industry News: Thalidomide
News Release - December 8, 2006
49 Abstracts Evaluating Revlimid(R) To Be Presented at The 48th American Society of Hematology Meeting131 Abstracts Investigating Celgene Products in Single and Combination Therapies in a Broad Range of Hematological Cancers
SUMMIT, N.J., Dec. 8 (HSMN NewsFeed) -- Celgene Corporation (Nasdaq: CELG ) announced today that clinical investigators from leading cancer research centers will present data from recent and on-going clinical trials of REVLIMID (lenalidomide) at the American Society of Hematology 48TH Annual Meeting, considered the premier educational and scientific event in the hematology/oncology international community, in Orlando, FL from December 9- 12, 2006.
REVLIMID is only indicated for use as a treatment in combination with dexamethasone for the treatment of patients with multiple myeloma 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.
Multiple Myeloma (MM):
-- Lenalidomide plus Bortezomib in Relapsed and/or Refractory Multiple Myeloma (MM): Final Results of a Multicenter Phase I Trial; Abstract 0405
-- Lenalidomide, Adriamycin and Dexamethasone Chemotherapy (RAD) in Relapsed Multiple Myeloma- First Results of a German Multicenter Phase I/II Trial; Abstract 0408
-- Lenalidomide Plus Dexamethasone in Newly Diagnosed Myeloma: Response to Therapy, Time to Progression and Survival; Abstract 0798
-- A Randomized Phase III Trial of Lenalidomide Plus High-dose Dexamethasone versus Lenalidomide plus Low-dose Dexamethasone in Newly Diagnosed MM (E4A03): A Trial Coordinated by the Eastern Cooperative Oncology Group; Abstract 0799
-- Oral Lenalidomide Plus Melphalan and Prednisone (R-MP) for Newly Diagnosed Multiple Myeloma: Results of a Multicenter Phase I/II Study; Abstract 0800
-- Expanded Access Program (EAP) for Lenalidomide plus Dexamethasone in over 1400 Subjects with Relapsed or Refractory Multiple Myeloma; Abstract 3556
-- Lenalidomide Plus High-Dose Dex Provides Compared to High-Dose Dex Alone for Relapsed or Refractory MM: Results of 2 Phase III Studies (MM-009, MM-010) and Subgroup Analysis of Patients with Impaired Renal Function; Abstract 3547
-- Use of Lenalidomide +/- Corticosteroids in Relapsed/Refractory Multiple Myeloma Patients with Elevated Baseline Serum Creatinine Levels; Abstract 3548
-- Lenalidomide Induced Myelosuppression is Potentially Associated with Renal Dysfunction in Treatment Naive Myeloma (MM) Patients Receiving BiRD (Biaxin /Rev/Dex) Combination Therapy (Rx); Abstract 3549
-- Lenalidomide +/- Corticosteroids in Elderly Multiple Myeloma Patients with Relapsed/Refractory Multiple Myeloma; Abstract 3550
-- Lenalidomide in Combination with Dexamethasone results on TTP in Elderly Patients with Relapsed or Refractory Multiple Myeloma (MM); Abstract 3551
-- Lenalidomide in Combination with Dexamethasone compared to Dexamethasone at First Relapse in Relapsed Multiple Myeloma; Abstract 3552
-- Lenalidomide in Combination with Dex compared to Dex in Patients Who Have Received Prior Thalidomide for Relapsed or Refractory Multiple Myeloma; Abstract 3553
-- Lenalidomide in Combination with Dex results on TTP in Non-SCT Patients with Relapsed or Refractory MM: Analysis from MM-009 and MM- 010 Randomized Phase III Clinical Trials; Abstract 3554
-- Lenalidomide in Combination with Cyclophosphamide and Dexamethasone (CRD) in Heavily Pre-Treated Myeloma Patients; Abstract 3555
-- Lenalidomide and Poor Prognosis Conferred by Deletion of Chromosome 13 and t(4;14) in Multiple Myeloma: MM016 Trial; Abstract 3557
-- Melphalan (M), Prednisone (P) and lenalidomide ® combination (MPR) for Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for Stem Cell Transplantation; Abstract 3558
Myelodysplastic Syndromes (MDS):
-- Lenalidomide in Patients with Myelodysplastic Syndrome Without Del 5q Cytogenetic Abnormalities; Abstract 0250
-- Lenalidomide in Patients with Myelodyplastic Syndrome and Chromosome Deletion 5q; Abstract 0251
-- Conventional Cytogenetics and FISH for EGR1 To Detect Deletion 5q in Hematological Disorders and To Assess Response to Treatment with Lenalidomide; Abstract 2351
-- An Erythroid Differentiation Gene Expression Signature Predicts Response to Lenalidomide in Myelodysplasia; Abstract 2668
-- Lenalidomide in patients with del (5q) myelodysplastic syndrome with a complex karyotype; Abstract 4860
-- A Pharmacokinetic Pharmacodynamic Study of Oral Lenalidomide in Patients with Low- or Intermediate-1-Risk MDS; Abstract 4854
Chronic Lymphocytic Leukemia:
-- Lenalidomide in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL): Final Results of a Phase II Clinical Trial; Abstract 0306
-- Lenalidomide in Patients With Relapsed and Treatment Refractory Chronic Lymphocytic Leukemia (CLL); Abstract 0305
-- Low Dose Prednisone decreases the severity but not the frequency of Lenalidomide associated Tumor Flare Reaction (TFR) in CLL Patients; Abstract 4987
-- Cardiac Biomarkers Predict for Ability to Tolerate and Complete Therapy with Lenalidomide (plusmn) Dexamethasone in AL; Abstract 0130
Acute Myeloid Leukemia:
-- Hematologic and Cytogenetic Results Evaluating Lenalidomide Therapy in an 82 Year Old Female with Acute Myeloid Leukemia (AML) Arising from JAK2, V617F Positive, del(5)(q13q33) Myelodysplastic Syndrome (MDS); Abstract 4827
-- Preliminary Results from a Phase II Study of Lenalidomide Monotherapy in Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma; Abstract 0531
-- Early Results From a Phase II Study of Lenalidomide Monotherapy in Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma; Abstract 2482
Polycythemia Rubra Vera:
-- Splenic Infarction in a Patient with Spent-Phase Polycythemia Rubra Vera (PRV) Treated with Lenalidomide; Abstract 4903
-- Lenalidomide and CC-4047 Inhibit the Proliferation of Namalwa Cancer Cells While Expanding CD34 + Progenitor Cells. New Insights on the Combination Therapy with Certain HDAC Inhibitors for Hematological Cancers; Abstract 1120
-- Pro-Apoptotic Effect of Lenalidomide in Patients with Chronic Lymphocytic Leukemia (CLL) Is Possibly Mediated through Interruption of the Phosphatidylinositol Pathway; Abstract 2102
-- First Clinical Evidence of In Vivo Natural Killer (NK) Cell Modulation in Chronic Lymphocytic Leukemia (CLL) Patients (pts) Treated with Lenalidomide (L); Abstract 2109
-- Lenalidomide ([Revlimid]) and Monoclonal Antibody-Associated Anti- Tumor Activity Against Rituximab-Sensitive and Rituximab-Resistant B- Cell Lymphoma Cell Lines; Abstract 2522
-- Lenalidomide Up-Regulates SPARC and Inhibits In Vitro Growth of the Malignant Clone in Myelodysplastic Syndrome Patients with 5q Deletion.; Abstract 0855
-- Lenalidomide (CC5013) Alters a T Cell Homeostatic Check-Point in Patients With Myelodysplastic Syndrome (MDS); Abstract 0851
-- Lenalidomide (CC-5013) and Erythropoiesis in Myelodysplastic Syndromes (MDS) by CD45 Protein Tyrosine Phosphatase (PTP) Inhibition; abstract 1360
-- Lenalidomide (CC5013) and T Helper-1 Function Bias to Autologous Bone Marrow Antigens in MDS; Abstract 2659
-- Large CD45 Protein Tyrosine Phosphatase (PTP) Isoforms Predominate in Myelodysplastic Erythroid Precursors & Attenuate the Erythropoietin (EPO): STAT5 Signal; Abstract 2650
-- Killing of Drug-Sensitive and Resistant Myeloma Cells and Disruption of Their Bone Marrow Stromal Interaction by HuLuc63, a Novel Humanized Anti-CS1 Monoclonal Antibody; Abstract 3470
-- Lenalidomide and Bortezomib Inhibit Osteoclast Differentiation and Activation in Multiple Myeloma: Clinical Implications; Abstract 3485
-- Reduced Natural Killer Function Accompanies MDS Disease Progression and is Restored by Lenalidomide (CC5013) via a Mechanism Divergent From Interleuken-2 (IL-2); Abstract 2651
-- In Vitro Generation of Highly Purified Functional Invariant NKT Cells in Multiple Myeloma: A Strategy for Immunotherapy; Abstract 5104
-- Quantitative Detection Using SYBR Green of Residual Disease in Myeloma Patients Treated with Lenalidomide or Velcade; Abstract 5102
-- The IMiDs® Immunomodulatory Drugs Lenalidomide and CC-4047 and Growth Arrest and Apoptosis in NHL Tumor Cells In Vitro; Abstract 2388
-- Lenalidomide and Natural Killer (NK) Cell Mediated Antibody-Dependent Cellular Cytotoxicity (ADAA) of Rituximab Treated Non-Hodgkin's Lymphoma Cell Lines In Vitro; Abstract 3714
-- The Incidence and impact of Thrombocytopenia in Myelodysplastic Syndrome (MDS); Abstract 2617
-- Deep Vein Thrombosis in Myeloma: Estimate of Prevalence and Recommendations for Therapy Based Upon a Survey of Members of the International Myeloma Working Group (IMWG); Abstract 3571
-- REVLIMID is only indicated for use as a treatment in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Del 5q Myelodysplastic Syndromes
-- 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.
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® (lenalidomide).
Special Prescribing Requirements
BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL EXPOSURE TO REVLIMID (lenalidomide), REVLIMID® (lenalidomide) IS ONLY AVAILABLE UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM. THIS PROGRAM IS CALLED "RevAssist®". 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® (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® (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®): 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 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® 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.
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 1-888-4CELGENE. 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.
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® and RevAssist® 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.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.