Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

December 1, 2010, from 8 a.m. to 5 p.m.

Agenda: On December 1, 2010, the committee will discuss supplemental new drug applications (sNDAs) 021-319/S-024, trade name AVODART (dutasteride) Soft Gelatin Capsules,manufactured by SmithKline Beecham Corp. d/b/a (doing business as) GlaxoSmithKline and 020-180/S-034, trade name PROSCAR (finasteride)Tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposedexpansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined.