SUMMIT, N.J.--(BUSINESS WIRE)--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. Additionally, 45 percent of patients who were red blood cell transfusion independent (RBC TI) at baseline achieved red blood cell transfusion independence versus 11 percent of patients receiving CCR treatment (p<0.0001) and 85.3% of patients treated with Vidaza who were RBC TI at baseline remained RBC TI. Investigators aimed to treat patients until disease progression, relapse after response or unacceptable toxicity; the median number of cycles of Vidaza was 9.

In the AZA-001 study, the most commonly occurring adverse reactions (all grades) were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%) and febrile neutropenia (12.6%)..

About VIDAZA®

In December 2008, VIDAZA became the first and only drug approved by the European Commission to demonstrate a significant extension of overall survival compared to conventional care regimens, for patients with Intermediate-2 and high-risk MDS and AML. Earlier in 2008 the U.S. FDA also included this extension of overall survival in its approved VIDAZA indication for treatment of all five French, American, British (FAB) MDS subtypes, which includes both low-risk and high-risk patients. These subtypes include: refractory anemia (RA), Refractory anemia with ringed sideroblasts (RARS) if accompanied by neutropenia, or thrombocytopenia or requiring transfusions, Refractory anemia with excess blasts (RAEB), Refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukaemia (CMML). The more recent WHO classification system incorporates RAEB-T patients within the AML category. VIDAZA has received orphan drug designation in several markets including the European Union, the U.S. and Japan.

VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and cytotoxicity of abnormal hematopoietic cells in the bone marrow. DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancer-suppressing functions to cancer cells. The cytotoxic effects of VIDAZA cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to VIDAZA. VIDAZA was approved by FDA for IV administration in January 2007.

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. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with median survival rates ranging from approximately six months to six years for the different classifications of MDS. 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 Celgene Corporation

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company’s Web site at www.celgene.com.

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.