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Dendreon submits clinical and non-clinical sections of rolling BLA to U.S. FDA for Provenge
2006 SEP 18 -- Dendreon Corporation (DNDN) announced that the company has submitted the clinical and non-clinical sections of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Provenge (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent (also known as hormone-refractory) prostate cancer.
The company plans to submit the chemistry, manufacturing and controls (CMC) section later this year, which will complete the submission of the BLA to the FDA for approval to market Provenge.
The clinical section of the BLA contains...
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