In additional news breaking today:
- Dendreon Corp. is predicting interim results of the IMPACT study of Provenge in metastatic, androgen-independent prostate cancer by October 2008
- The FDA has refused to approve an experimental, topical treatment for erectile dysfunction
Dendreon has recently issued a media release stating that the company is expecting an interim analysis of overall survival from the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE® (sipuleucel-T) to occur in October this year. PROVENGE is an investigational active cellular immunotherapy for the treatment of advanced prostate cancer. The US FDA had requested additional clinical data to support the proposed efficacy claim for Provenge, and has apparently also indicated that a positive interim analysis or final analysis for overall survival from the IMPACT trial would be sufficient to address the request for additional information to support the proposed efficacy claim. If the IDMC reports in October that the pre-specified criterion for statistical significance is not met, then the company anticipates continuing the trial with the expectation of reporting final results in the second half of 2009.
The IMPACT trial is a multicenter, randomized, double-blind, placebo-controlled Phase III study, which enrolled just over 500 men with metastatic, androgen-independent prostate cancer with a primary endpoint of overall survival.
According to another media release, the FDA has issued a non-approvable letter to NexMed for its experimental topical therapy for erectile dysfunction (ED). According to NexMed, the rejection of the application is related to a mouse carcinogenicity study carried out in 2002. NexMed says that it will evaluate the FDA letter and then address the issues in a response. The “New” Prostate Cancer InfoLink is unable to establish whether there was any expectation that this product might have been effective in treatment of ED in prostate cancer patients.
Filed under: Drugs in development, Management, Treatment | Tagged: cancer vaccine, Dendreon, ED, erectile dysfunction, hormone, NexMed, prostate, Provenge, refractory |
THE "NEW" PROSTATE CANCER INFOLINK 