Analysis shows revlimid plus dexamethasone increases overall survival in multiple myeloma patients

December 11, 2008

Celgene International Sarl (NASDAQ: CELG) announced that data from a landmark analysis of patients with relapsed/refractory multiple myeloma found that continuous treatment with REVLIMID (lenalidomide) in combination with dexamethasone after achieving best response resulted in significantly longer overall survival and increased time to disease progression compared to those who discontinued treatment after ten months or less. The results of this analysis were presented today at the 50th Annual Meeting of the American Society of Hematology (ASH).

"The findings show that, as long as patients are responsive to treatment and their side effects are manageable, they should be maintained on therapy, since continuing treatment can improve outcomes and overall survival significantly," said Jesus San Miguel, MD, Head of the Department of Hematology, University of Salamanca, and lead author on the study. "Patients and doctors should work together to manage side effects so that treatments can be continued."

Multiple myeloma is a cancer of the blood in which plasma cells, or white blood cells, are overproduced in the bone marrow. The disease accounts for one-fifth of all deaths from hematologic cancers.

This analysis of 321 patients found that, 24 months after achieving their best response, 93.8 percent of patients who continued therapy for more than 10 months were still alive, whereas only 48.4 percent of those who were treated for 10 months or less survived.

A second analysis completed as part of the same study showed that patients who discontinued therapy with REVLIMID® early due to adverse events or withdrawal of consent had significantly shorter median overall survival times (29.5 months) and times to disease progression (13.6 months) than did those who continued therapy. For those who continued therapy median overall survival and time to progression were not yet reached at time of analysis. Patients who stopped treatment due to disease progression were excluded from the study; therefore the results show that patients benefit from continuing treatment.

REVLIMID is currently approved in the European Union, the United States, Canada, Argentina and Switzerland in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy. REVLIMID is also approved in Canada, the United States and Argentina for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland, Australia and Japan.

Celgene International Sàrl

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