Celgene MDS drug cuts risk of death by 42%

2 March 2009

Celgene says results published in The Lancet Oncology from AZA-001, a randomized Phase III study conducted in patients with higher-risk  myelodysplastic syndromes, indicate that Vidaza (azacitidine)  demonstrated a significant extension of overall survival compared to  conventional care regimens (CCR).

The median overall survival for people with Intermediate-2 and high-risk  MDS and acute myeloid leukemia with 20% to 30% bone marrow blasts  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), with a 42% reduction in the risk of death. The two-year  survival rate was nearly double at 50.8% for patients receiving the drug  versus 26.2% for placebo (p=0.0001).

In addition, 45% of patients achieved red-blood cell transfusion  independence vs 11% of those receiving CCR treatment (p<0.0001) and  85.3% of red-blood cell transfusion independent Vidaza subjects  remained so.

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