Celgene Withdraws European Union (EU) Marketing Authorization Application For Lenalidomide In Deletion-5Q Myelodysplastic Syndromes

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Lymphoma / Leukemia / Myeloma;  Clinical Trials / Drug Trials
Article Date: 05 Jun 2008 - 0:00 PDT

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Celgene International Sarl (NASDAQ: CELG) announced that, following discussions with the European Medicines Agency (EMEA) and the EMEA's Committee for Medicinal Products for Human use (CHMP), it has withdrawn its Marketing Authorization Application (MAA) for Lenalidomide - Celgene Europe (lenalidomide), which was intended for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality. The MAA is being withdrawn because the CHMP considers that the currently available data, obtained from a single-arm Phase II study, do not allow it to conclude on a positive benefit-risk balance.

Celgene International Sàrl is continuing its clinical development program of lenalidomide with the intention to seek marketing approval in MDS.

REVLIMID (lenalidomide) has obtained Orphan Drug designation for MDS in the EU, US, and Australia, Orphan Drug designation for multiple myeloma (MM) in the EU, US, Australia and Switzerland, and Orphan Drug designation for chronic lymphocytic leukaemia (CLL) in the EU. REVLIMID is approved for use in the US, Canada and Argentina for the 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. REVLIMID is also approved for use in the EU, US, Argentina and Switzerland for the treatment of multiple myeloma in combination with dexamethasone in patients who have received at least one prior therapy. Also, REVLIMID is approved in Australia for the treatment of multiple myeloma in combination with dexamethasone in patients whose disease has progressed after one therapy.

About REVLIMID®

REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 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 issued and pending patent applications including composition-of- matter and use patents.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. 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 involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in 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. The World Health Organization has also recently identified a unique subset of MDS patients with a "5q- Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.

About Celgene International Sárl

Celgene International Sárl, located in Boudry, 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 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® is a registered trademark 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.

http://www.celgene.com

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