Celgene given approval for Revlimid for multiple myeloma

New York, June 29 - Celgene Corp. said the Food and Drug Administration approved the company's Supplemental New Drug Application for an additional indication for Revlimid (lenalidomide).

The drug is now approved for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

Revlimid is also approved for use in the treatment of patients with transfusion-dependent anemia due to Low-or- Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Multiple myeloma is the second most common blood cancer in the United States, affecting approximately 50,000 people, Celgene noted. About 14,600 new cases of multiple myeloma are diagnosed each year and about 12,000 Americans are expected to die of multiple myeloma in 2006.

Revlimid is an analog of thalidomide and is only available under a special restricted distribution program. It is also associated with increased neutropenia and thrombocytopenia and increases the risk of deep venous thrombosis and pulmonary embolism.

Celgene, based in Summit, N.J, is a pharmaceutical company.

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