13 out of 17 FDA members felt Dendreon’s Provenge showed substantial efficacy.

The FDA recommended approval of the first therapeutic cancer vaccine, according to Dendreon. The final verdict is expected in mid May 2007. The company’s BLA is for sipuleucel-T, or Provenge, an autologous dendritic cell-based immunotherapy for men with asymptomatic metastatic hormone-refractory prostate cancer.

Data presented suggests a 4.5-month survival improvement in one trial of 127 patients and a 3.3-month survival increase in a second study of 98 patients compared to placebo. The survival difference from the first trial was statistically significant, while that of the second was not.

The advisory committee included 17 voting members who all found Provenge to be reasonably safe. Additionally, 13 of the 17 voted that the vaccine demonstrated substantial evidence of efficacy and recommended approval.   

“The recommendation of the Advisory Committee is a landmark for cancer immunotherapy development and presents an important step toward providing a novel generation of therapies to patients, which can offer clinical benefit with minimal toxicities,” notes Axel Hoos, chairman of the Cancer Vaccine Consortium executive council. “The recommendation reflects the growing confidence in cancer immunotherapy based on the progress in science and development as well as consensus building in the field in recent years. Should sipuleucel-T be approved, further progress in cancer immunotherapy development will likely occur at an accelerated pace.”

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