Healthcare Industry News: myelodysplastic syndromes
News Release - October 2, 2006
Updated REVLIMID(R) (lenalidomide) Clinical Results Presented at the 3rd International Conference on Innovative Therapies for Lymphoid MalignanciesPreliminary Phase II Data Evaluate REVLIMID Oral Therapy in Patients with Aggressive Non-Hodgkin's Lymphoma
PALERMO, Italy, Oct. 2 (HSMN NewsFeed) -- Celgene Corporation (Nasdaq: CELG ) announced clinical data from a multi-center, single arm open label Phase II clinical study evaluating and investigating single agent REVLIMID (lenalidomide) in patients with relapsed and refractory aggressive non-Hodgkins lymphoma (NHL) were reported at the 3rd International Conference on Innovative Therapies for Lymphoid Malignancies in Palermo, Italy on Thursday, September 28, 2006. 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.
NHL is the most common form of blood cancer in the United States affecting more than 360,000 people. Approximately 50 percent have aggressive NHL, while the other half have indolent or follicular lymphoma. According to the American Cancer Society, more than 56,000 men and women in the United States are diagnosed with NHL each year, and 19,000 are expected to die from NHL in 2006.
The data were presented at an oral presentation by Peter Wiernik, M.D., Director of Clinical Oncology at Our Lady of Mercy Medical Center, Bronx, New York. Preliminary results from a Phase II study (NHL-002) with single agent therapy REVLIMID in patients with relapsed or refractory aggressive (NHL) reported that 32 of the 40 patients were enrolled with 22 patients evaluable for response. Of the 22 evaluable patients, seven patients (32%) exhibited an objective response (2 complete responses unconfirmed (CRu) and 5 partial responses (PR)) Six patients had stable disease (SD) for a tumor control rate (TCR) of 59%.
Responses were observed in each of the aggressive histologic subtypes studied, including: Three of 12 patients (25%) with diffuse large cell lymphoma; One of three patients (33%) with follicular lymphoma; Two of 5 patients (40%) with mantle cell lymphoma; and one of two patients (50%) transformed. Five of 11 patients (45%) with 1-2 prior treatment regimens had an objective response, as did 2 of 3 patients (67%) who had received a prior stem cell transplant. Median time-to-response was 2 months.
In this clinical study, Grade 3 or 4 adverse events occurred in 18 of 31 (58%) patients receiving drug. The Grade 3 hematological adverse reactions observed were neutropenia and thrombocytopenia with 4 patients (13%) experiencing a Grade 4 adverse reaction.
The most frequently reported adverse events with REVLIMID in deletion 5q MDS patients were thrombocytopenia (62%) and neutropenia (59%). In multiple myeloma, the most frequent Grade 3 or 4 hematological adverse events observed were in patients who received combination oral therapy REVLIMID and dexamethasone.
"Based on the results of this oral presentation and data from additional patients under study we are advancing our clinical and regulatory strategies for the evaluation of REVLIMID in NHL," said Sol J. Barer, Ph.D., Chief Executive Officer of Celgene Corporation.
About the Trial
The Phase II multi-center, single arm, open label trial was designed to evaluate and investigate the therapeutic potential and safety of REVLIMID® oral monotherapy in 40 patients with relapsed or refractory aggressive NHL following one or more prior treatment regimen. Thirty-one patients age 46-83 (median age 65), with relapsed or refractory aggressive NHL had received a median number of 2.5 prior therapies (range: 1-6). Patients in the study received 25 mg of REVLIMID orally once daily for days 1-21 in a 28-day cycle and continued therapy for 52 weeks as tolerated or until disease progression.
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 http://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 http://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.
About Non-Hodgkins Lymphoma
Non-Hodgkin's lymphoma (NHL) is a cancer of B or T cells in the lymph system. NHL encompass over 29 types of lymphoma and are characterized by the US National Cancer Institute as aggressive (fast growing) and indolent (slow growing). Aggressive lymphomas, also known as intermediate and high-grade lymphomas, tend to grow and spread quickly and cause severe symptoms. Indolent lymphomas, also referred to as low-grade lymphomas, tend to grow quite slowly and cause fewer symptoms.
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 http://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.
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