Company readies FDA application for prostate cancer immunotherapy

October 6, 2005

Dendreon Corp. said it plans to submit a biologics license application to the FDA to market APC8015 (Provenge), an investigational immunotherapy for the treatment of prostate cancer.

Dendreon Corp. said it plans to submit a biologics license application to the FDA to market APC8015 (Provenge), an investigational immunotherapy for the treatment of prostate cancer.

A 3-year follow-up of the D9901 phase III trial of the therapy in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a median survival benefit of 21% or 4.5 months and a three-fold improvement in survival at 36 months for patients randomized to receive APC8015 or placebo, according to the company. A final 3-year follow-up of the D9902A phase III trial in 98 men showed a 20% improvement in median survival. The therapy was well tolerated, with the most common adverse events being fever and chills lasting for 1 or 2 days.