Dendreon announced today that the FDA will accept “either a positive interim or final analysis of survival” from its ongoing Phase III randomized clinical trial of Provenge immunotherapy for androgen independent prostate cancer.

In a press release, the company said it “has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to supplement the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.”

“We anticipate completing enrollment in the … study this year and anticipate interim survival results in 2008,” Dendreon said in the press release.

Provenge, classed as a therapeutic vaccine, is designed to stimulate the immune system to fight existing tumors. Immune system cells from the individual patient’s blood are boosted and multiplied by culturing with a stimulating factor (GM-CSF) and primed to seek and destroy cells expressing prostatic acid phosphatase (PAP), an antigen overexpressed especially by advanced prostate cancer that has spread to bone. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy, the company says.

For the impact of Dendreon’s announcement on the company’s stock see:
Dendreon cites data needed by FDA, shares soar. Reuters

FDA to Accept Interim Data On Dendreon’s Provenge
By BRETT PHILBIN WSJ (free article)

Dendreon rises with lesser data required BusinessWeek.