Two major Phase III studies report oral Revlimid(R) (lenalidomide) plus dexamethasone shows increased overall survival advantage

26-Nov-2007

The New England Journal of medicine published updated data from two phase III studies that showed a combination treatment of oral lenalidomide plus dexamethasone increased overall survival and slowed disease progression in previously treated patients with multiple myeloma compared to dexamethasone plus placebo. Revlimid is currently under review by Health Canada for the treatment of multiple myeloma and MDS with deletion 5q.

"The experience at our centre with lenalidomide has been extremely positive," says Dr. Christine Chen, co-author of the NEJM paper and hematologist within the Myeloma Clinical Research Group at Princess Margaret Hospital and the largest recruiting hospital across North America for this trial. "The trial demonstrates that patients treated with lenalidomide and dexamethasone respond better and for greater periods of time, experience slower progression of disease, and survive longer than those treated with dexamethasone plus placebo. Also, lenalidomide is an oral drug thus it allows patients to take the medication at home and remain as independent as possible."

The North American Phase III pivotal study (MM-009) evaluated lenalidomide plus dexamethasone in 353 multiple myeloma patients. Those included in the trial had been heavily treated prior to enrollment, many having failed three or more rounds of therapy with other agents.

Revlimid is a medicine containing the active substance lenalidomide. It is the first of Celgene's group of proprietary compounds of immunomodulatory agents called IMiDs(R). 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 U.S. and foreign issued and pending patent applications including composition-of-matter and use patents.

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