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New Drug for Prostate Cancer Gets FDA Nod. http://www.nytimes.com/2012/09/01/business/fda-approves-prostate-cancer-drug.html?ref=policy&_r=0. Andrew Pollack The New York Times August 31, 2012. Prostate Cancer. Expected 241,000 new cases this year and 28,000 deaths
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New Drug for Prostate Cancer Gets FDA Nod http://www.nytimes.com/2012/09/01/business/fda-approves-prostate-cancer-drug.html?ref=policy&_r=0 Andrew Pollack The New York Times August 31, 2012
Prostate Cancer • Expected 241,000 new cases this year and 28,000 deaths • Lupron is the usual treatment, which induces a chemical castration (suppressed testosterone production). • Before 2004, docetaxel (chemotherapy) was the only option for advanced prostate cancer. • Other options: Jevtana, Provenge, and Zytiga
Xtandi (enzalutamide) • Life-prolonging drug for men with late-stage prostate cancer • Blocks testosterone from enhancing cancer growth • Clinical trials: • Median of 18.4 months (with Xtandi) • Median of 13.6 months (with placebo) • Cost is $7,450/month (higher than expected)
FDA Approval • Approval after only a 3-month review • Priority Review Program is usually 6 months. • After a long period of no new treatment options, Xtandi is one of several to come to the market within the last 2 years. • Most worrisome side effect are seizures, which were found by 1% of men in the clinical trial.
Xtandi vs. Zytiga • Both are pills (previous drugs are injections) • Both aimed at men with late-stage prostate cancer that has spread. • Both approved for men who have already tried docetaxel. • No head-to-head clinical trials. • Advantage for Xtandi-does not have to be given with prednisone as Zytiga does.
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