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Dendreon Receives Complete Response Letter from FDA for Provenge BLA
Dendreon Corporation (Seattle, WA, www.dendreon.com) received a complete response letter, commonly referred to as an "approvable" letter, on May 8, 2007, from the FDA regarding its biologics license application (BLA) for Provenge (sipuleucel-T) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
Dendreon Corporation (Seattle, WA, www.dendreon.com) received a complete response letter, commonly referred to as an “approvable” letter, on May 8, 2007, from the FDA regarding its biologics license application (BLA) for Provenge (sipuleucel-T) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The company is seeking a clarification from the FDA as to the nature of the data that are being requested. The agency has also requested additional information with respect to the chemistry, manufacturing, and controls (CMC) section of the BLA, which the company believes it can supply to the FDA in a timely manner.
On March 29, 2007, the FDA’s Office of Cellular, Tissue, and Gene Therapies Advisory Committee was asked if the submitted data established that Provenge is reasonably safe and whether there is substantial evidence that the product is efficacious. The Advisory Committee voted 17 to 0 in favor of the safety of the drug and 13 to 4 in favor of its efficacy.