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FDA Review of Olaparib

Unfortunately, ODAC voted against approval of olaparib at the conclusion of the June 25, 2014 hearing. While olaparib showed improvement in progression-free survival, it did not show an improvement in overall survival for the women who took it in the clinical trials. Because there are no approved maintenance drugs currently on the market for ovarian cancer, the trials compared the side effects of olaparib to a placebo (i.e. no treatment at all). Olaparib had more side effects and adverse events than the placebo, so the advisory committee decided the benefits didn't outweigh the risks.

The panel did not take into account the fact that taking olaparib delays a woman's need to go back on chemotherapy; a treatment shown to be more toxic than olaparib. While this vote is not the final decision, the FDA will likely follow ODAC's recommendation and the therapy will be reconsidered after the conclusion of additional research. See our blog about this decision and learn more about PARP inhibitors.

Page updated 7/28/14

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