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New Drug for Prostate Cancer Gets FDA Nod

FDA approves Xtandi, a new drug for late-stage prostate cancer. Xtandi blocks testosterone to inhibit cancer growth. Clinical trials showed an increase in median survival compared to placebo. Potential side effects include seizures. Xtandi and Zytiga are both pills approved for men who have already tried docetaxel.

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New Drug for Prostate Cancer Gets FDA Nod

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  1. 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

  2. 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

  3. 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)

  4. 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.

  5. 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.

  6. The Economics Price PM MC D MR QC QM Quantity PC

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