Pill Identifier App

113 Abstracts Evaluating Celgene Products to Be Presented at the 49th American Society of Hematology Meeting

SUMMIT, N.J.--(BUSINESS WIRE)--Dec 5, 2007 - 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 49th Annual Meeting, considered the premier educational and scientific event in the hematology/oncology international community, in Atlanta, GA from December 8-11, 2007.

Clinical and scientific research abstracts on REVLIMID will be presented in oral and or poster sessions as an exchange of recent and updated scientific and clinical information by clinical investigators at the American Society of Hematology proceedings.

REVLIMID has obtained Orphan Drug designation in the EU, U.S., and Australia. REVLIMID is approved for use as an oral treatment in multiple myeloma in combination with dexamethasone by the European Medicines Agency (EMEA) REVLIMID is currently approved in the US by the U.S. Food and Drug Administration (FDA) for multiple myeloma in combination with dexamethasone for patients who have received at least one prior therapy. REVLIMID is also approved 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 by the FDA. Most adverse events and Grade 3/4 adverse events were more frequent in MM patients who received the combination of REVLIMID / dexamethasone compared to placebo / dexamethasone. Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events observed in the del 5q MDS population. -0-


----------------------------------------------------------------------

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(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

Multiple Myeloma

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.

CONTRAINDICATIONS:

Hypersensitivity: REVLIMID(R) (lenalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components.

PRECAUTIONS:

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.

ADVERSE REACTIONS:

Multiple Myeloma

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%).

Myelodysplastic Syndromes

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 (16%).

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.

About REVLIMID(R)

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 75 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 use patents.

About RevAssist(R)

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.

About Celgene

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 www.celgene.com.

REVLIMID(R) and RevAssist(R) are registered trademarks of Celgene Corporation.

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.

Contact

Celgene Corporation
David Gryska, 908-673-9059
Sr. Vice President and Chief Financial Officer
or
Brian P. Gill, 908-673-9530
Vice President, Global Corporate Communications

Posted: December 2007

View comments

Hide
(web4)