Transcript Vujic_New Drug for Prostate Cancer Gets FDA

New Drug for Prostate Cancer
Gets FDA Nod
Andrew Pollack
The New York Times
August 31, 2012
http://www.nytimes.com/2012/09/01/business/fda-approves-prostate-cancer-drug.html?ref=policy&_r=0
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.
The Economics
Price
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Quantity
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