Dendreon Completes Submission of Biologics License Application for PROVENGE
Mon, 11/02/2009 - 4:03am
Dendreon Corporation today announced that it has completed the submission of the amendedBiologics License Application (BLA) for PROVENGE (sipuleucel-T), theCompany's lead investigational product, to the U.S. Food and DrugAdministration (FDA). Dendreon is seeking licensure for PROVENGE for men withmetastatic castrate-resistant prostate cancer (CRPC). If approved by the FDA,PROVENGE would represent the first product in the new therapeutic class knownas active cellular immunotherapies. The amended BLA includes data from the IMPACT (IMmunotherapy for ProstateAdenoCarcinoma Treatment) trial, which was conducted under a Special ProtocolAssessment agreement with the FDA. The IMPACT study met its pre-specifiedprimary endpoint demonstrating a statistically significant improvement inoverall survival in men with metastatic CRPC. "With the BLA submission complete, we have taken an important step towardsreaching our goal of bringing a new therapy to men with advanced prostatecancer," said Mitchell H. Gold, MD, president and chief executive officer ofDendreon. "We look forward to working with the FDA to potentially makePROVENGE the first active cellular immunotherapy to be licensed in the UnitedStates."