FDA issues complete response letter for 5-ARI PCa risk reduction indication

February 10, 2011

GlaxoSmithKline has received a complete response letter from the FDA for the supplemental new drug application for dutasteride (Avodart) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum PSA level.

GlaxoSmithKline has received a complete response letter from the FDA for the supplemental new drug application for dutasteride (Avodart) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum PSA level.

A complete response letter is issued by the FDA’s Center for Drug Evaluation and Research when the review of a file is completed and it cannot be approved in its present form. This notification refers solely to the supplemental file specific to a prostate cancer risk reduction indication for dutasteride and not its existing FDA-approved use, namely the treatment of symptomatic BPH.

A GlaxoSmithKline spokesman said the company was reviewing the concerns raised in the FDA letter and would then discuss with the FDA possible next steps.

"We have not made any final decision on our next steps pertaining to this supplemental file," the spokesman told Urology Times.

In December 2010, an FDA Oncologic Drugs Advisory committee voted against the use of dutasteride and another 5-alpha-reductase inhibitor, finasteride (Proscar), for reducing the risk of prostate cancer.