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Article: ODAC Panel Backs Celgene's Single Study Data On Revlimid.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
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Washington Editor
BETHESDA, Md. - The FDA's Oncologic Drugs Advisory Committee voted 10-5 in favor of approving Celgene Corp.'s Revlimid (lenalidomide) for myelodysplastic syndromes (MDS) in transfusion-dependent patients with a 5q-deletion chromosomal abnormality.
"To my knowledge, there has not been an agent that gives that type of complete transfusion independence, clinical response associated with both a cytogenic remission and bone marrow normalization, and hemoglobin normalization," Sol Barer, Celgene's president and chief operating officer, told BioWorld Today. "We really do think that this is going to be one of the largest oncology products in ...