First And Only Agent To Significantly Extend Survival For Patients With Higher-Risk Myelodysplastic Syndromes (MDS)

First and Only Agent to Nearly Double the Two-Year Overall Survival Rate

Celgene Corporation (Nasdaq: CELG) today announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology™ v1.2010 and has upgraded VIDAZA® to a Category 1 recommended treatment for patients with intermediate-2 and high-risk myelodysplastic syndromes (MDS).

The NCCN consensus recommendation was based on the recent update to the US label and the weight of clinical evidence for VIDAZA. In AZA-001, the largest international, randomized Phase III study ever conducted in higher-risk MDS, VIDAZA demonstrated a near doubling of overall survival rates at 2 years compared to conventional care regimens (CCR). Based on these findings and because VIDAZA is the only agent to have a proven survival benefit, NCCN designated VIDAZA as the preferred agent for patients with Int-2 and High Risk MDS. Category 1 is the highest level of supporting evidence in the NCCN rating system. This decision reinforces current clinical utilization in the United States and supports ongoing regulatory filings internationally.

“The recommendation of VIDAZA within the NCCN guidelines is an important resource for the clinical treatment of patients with higher-risk MDS,” said Dr. Alan List Physician-In-Chief of the H. Lee Moffitt Cancer Center in Tampa, Fla. “Medical practice in oncology is often shaped by significant, peer-reviewed clinical evidence and these guidelines represent a noteworthy convergence of both this study and expert experience.”

In the AZA-001 study, the median overall survival for patients treated with VIDAZA (n=179) was 24.5 months compared to 15 months for those receiving CCR treatment (n=179), an improvement of 9.5 months (p=0.0001) in the primary endpoint for the study. CCR includes best supportive care, low-dose ARA-C, and standard chemotherapy. There was a 42 percent reduction in the risk of death (0.58 hazard ratio, 95% CI: 0.43-0.77). The two-year survival rate was nearly doubled at 50.8 percent for patients receiving VIDAZA versus 26.2 percent for patients receiving CCR (p<0.0001). The extension of survival was seen across all patient subgroups including those greater than 65 years of age and those with poor cytogenetics, a poor prognostic factor. This survival benefit was also seen in 32 percent of patients with AML as classified by the World Health Organization.