Key Ad Comm vote on Wednesday for olaparib

The FDA's Oncologic Drugs Advisory Committee meets Wednesday to decide if AstraZeneca's (AZN -1.2%) cancer drug olaparib should be given an accelerated approval or wait for the final results of the ongoing SOLO-2 clinical trial. The panel will discuss the results of Study 19 where olaparib demonstrated an 83% reduction in risk of progression or death in patients with ovarian cancer. There appears to be questions regarding the validity and reproducibility of the magnitude of the treatment effect, however. The committee will decide if the treatment benefits outweigh the side effects risk.

If the panel votes to wait until the completion of the SOLO-2 study, U.S. approval will not happen until 2016 considering the trial's mid-2015 final data collection date.

The company forecasts olaparib peak sales of $2B which places it in the top six pipeline candidates that it included in its recent investor presentation.

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  • Small Pharma Analyst
    , contributor
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    The outcome of this vote will impact Tesaro (TSRO) who also have a PARP inhibitor in Phase 3. If the ADCOM does not recommend approval of olaparib, then Tesaro could be first to market with niraparib for ovarian cancer. A relatively cheap way to play a potential negative ADCOM vote and resulting large upside for TSRO is to buy the July 35 call option for $0.41. (Jun 23 closing price for the stock was $30.15).
    23 Jun 2014, 04:43 PM Reply Like
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