Celgene Corporation
Jun 4, 2010
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Evaluation of REVLIMID® in Patients with Either GCB or Non-GCB Diffuse Large B-Cell Lymphoma Presented at ASCO

BOUDRY, Switzerland, Jun 04, 2010 (BUSINESS WIRE) --Celgene International Sàrl (NASDAQ:CELG) today announced researchersat the annual meeting of the American Society of Clinical Oncology presented data from an evaluation of lenalidomide (REVLIMID) in patients with diffuse large B-cell lymphoma (DLBCL) either with a germinal center B-cell (GCB) or non-germinal center B-cell (non-GCB) phenotype.

Investigators retrospectively analysed pooled patient data from four academic centers around the world for differences in clinical outcomes among patients with either GCB or non-GCB large-cell lymphoma treated with salvage lenalidomide. The initial data set included 40 patients with relapsed or refractory DLBCL with 23 classified as GCB and 17 classified as non-GCB.

Results of the evaluation showed an overall response rate of 53% (9/17) for non-GCB patients versus 8.7% (2/23) for GCB patients (p=0.006), including 23.5% (5/17) of non-GCB patients achieving a complete response versus 4.3% (1/23) of GCB patients. The median progression-free survival for non-GCB patients was 6.2 months versus 1.7 months for GCB patients (p=0.004).

The most common adverse events were consistent with those seen in other lymphoma studies of lenalidomide.

These data are from an investigational study. REVLIMID does not have marketing approval for the treatment of patients with previously treated DLBCL.

About REVLIMID
REVLIMID is an IMiDs® compound. REVLIMID and other IMiDs continue to be evaluated in over 100 clinical trials. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of- matter and use patents.

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID® is also approved in the United States, Canada and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorisation Applications are currently being evaluated in a number of other countries.

REVLIMID(lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.

REVLIMID (lenalidomide) is indicated for patients with transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Important Safety Information

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 (lenalidomide).

Male Patients:It is not known whether lenalidomide is present in the semen of patients receiving the drug.Therefore, males receiving REVLIMID(lenalidomide) must always use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy.

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. In the US, this program is called "RevAssist®". Under this program, only prescribers and pharmacists registered with the program can 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. HAEMATOLOGIC TOXICITY (NEUTROPAENIA AND THROMBOCYTOPAENIA).

This drug is associated with significant neutropaenia and thrombocytopaenia.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 haematologic 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® (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 the 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.

ADDITIONAL WARNINGS: HAEMATOLOGIC TOXICITY

Multiple Myeloma

CONTRAINDICATIONS:

Pregnancy Category X:

Hypersensitivity:

PRECAUTIONS:

Angioedema, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Tumour Lysis Syndrome

Renal impairment:

Nursing mothers: It is not known whether REVLIMID (lenalidomide) is excreted in human milk.

ADVERSE REACTIONS:

Multiple Myeloma

Other adverse events reported in multiple myeloma patients (REVLIMID (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%), neutropaenia (28% vs 5%), anaemia (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%), thrombocytopaenia (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® (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:

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and ADVERSE REACTIONS.

About non-Hodgkin's lymphoma

Lymphoma is the name for the group of blood cancers that start in the lymphatic system, which is part of the body's immune system. Lymphomas generally start in the lymph nodes or outside of lymph nodes within lymphatic tissues located in organs such as the stomach or intestines. They may involve the marrow and the blood in some cases as well. There are many different kinds of non-Hodgkin's lymphoma (NHL). There are an estimated 360,000 patients with NHL in the U.S. with more than 63,000 new patients diagnosed annually.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialisation 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.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control. The Company's actual results, performance, or achievements could be materially different from those projected by these forward-looking statements.The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, 10-Q and 8-K reports.Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.

SOURCE: Celgene International Sàrl

Celgene International Sàrl
Kevin Loth, Director of External Relations
+41 32 729 86 21