Friday, biotechnology company Dendreon Corp. (DNDN) revealed that the U.S. Food and Drug Administration or FDA has accepted its amended Biologics License Application or BLA to market its candidate vaccine Provenge for prostrate cancer. The regulator is expected to take a decision on whether to approve the drug by May 1, 2010.
Dendreon is seeking licensure for Provenge for men with metastatic castrate-resistant prostate cancer or CRPC. Under a Special Protocol Assessment or SPA agreement with the FDA, the BLA includes data from the IMPACT trial or Immunotherapy for Prostate AdenoCarcinoma Treatment trial.
The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. The resubmission also contains the remaining information requested by the FDA pertaining to chemistry, manufacturing and controls section of the BLA for Provenge.
DNDN is currently trading at $28.06, up $0.01 or 0.05% on the Nasdaq.
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