13-Nov-14 10:00 AM  CST

New Ovarian Cancer Drug Already Approved in Europe could also help in the fight against Prostate Cancer

AstraZeneca announced this week that olaparib, a new ovarian cancer fight drug that has already been approved in Europe, might also help in the fight against prostate cancer. Olaparib, which is still seeking approval from the FDA and has the potential for 2 billion in annual sales, was developed to primarily treat ovarian and gastric cancer. However, Johann De Bono, a professor at the Institute of Cancer Research in London, told conference goers that the drug has potentially wider reaching capabilities, most prominently, the treatment of prostate cancer.

            The mechanism or olaparib works by blocking the enzymes associated with cell repair, and was specifically developed for those patients that may inherit the BRCA gene mutation, which is found commonly is ovarian, breast and gastric cancers. Dr. de Bono and his colleagues have already begun clinical testing for olaparib and prostate cancer. In fact research has already progressed to clinical phase II.

            As stated earlier olaparib is still waiting approval in the US. AstraZeneca petitioned for accelerated FDA approval of olaparib in June of 2014, but the drug’s approval was voted down by a count of 11-2 on the grounds that AstraZeneca need to provide more conclusive results after their phase 3 trials. Phase 3 trials for olaparib will be complete in 2015, at which time the FDA will reconsider approval of the drug.

Another concern for non-approval of the drug centered on the findings that some test patients using olaparib were actually developing secondary forms of cancer, such as acute myeloid leukemia, and melodysplastic syndrome. The incidence of secondary forms of cancer during phase 2 was approximately 2.2% with 1 case that was confirmed and 3 that were suspected.

 

 

 

References:

Hand, L. “FDA Panel Votes Against Accelerated Approval for Olaparib”06-26-14, Medscape, http://www.medscape.com/viewarticle/827404, referenced 7. November 2014

Hirschler, B. “AstraZeneca’s Olaparib may also work in Prostate Cancer: Expert”, 11-4-14, Reuters, http://www.reuters.com/article/2014/11/04/us-astrazeneca-cancer-idUSKBN0IO1QE20141104, referenced 7. November 2014


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Source: Sandy Andrews  

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