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Dendreon completes Provenge BLA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The Nov. 9 electronic submission of the chemistry, manufacturing and controls section of the application completes Dendreon's rolling BLA for the active cellular immunotherapy Provenge (sipuleucel-T). The company is requesting a priority review for the BLA, which seeks an indication for asymptomatic, metastatic hormone-refractory (androgen-independent) prostate cancer. Dendreon initiated the rolling BLA in August (1Pharmaceutical Approvals Monthly September 2006, p. 28)...

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