FDA Confirms Data Required For Provenge Licensure
U.S. Food and Drug Administration will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application 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.
"The FDA indicated that either a positive interim or final analysis of survival, as described in the IMPACT Special Protocol Assessment Agreement, would address their request for the submission of additional clinical data in support of our efficacy claim," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008. We are committed to making PROVENGE available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options."
Dendreon's BLA was submitted under a Fast Track designation and was accepted for filing by the FDA in January 2007. The BLA was based primarily on a multi-center, randomized, double-blind, placebo-controlled Phase 3 study (D9901) that showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE hada median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.
Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.