The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olaparib (Lynparza), an oral poly ADP-ribose polymerase (PARP) inhibitor, for monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic castration-resistant prostate cancer (mCRPC) in patients who received a prior taxane-based chemotherapy and at least one newer hormonal agent.1

Olaparib was given the designation based on results of the TOPARP-A phase 2 trial. Results from the trial were presented at the American Association for Cancer Research 2015 meeting and published in the New England Journal of Medicine in October 2015.

Researchers found that men with mCRPC with defective DNA damage repair mechanisms responded to olaparib, and that monotherapy with the drug may offer improvement over available therapies for treatment in the biomarker-selected population.

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“The Breakthrough Therapy designation for Lynparza is encouraging news for patients and their families, as there are currently very limited treatment options for mCRPC,” said Antoine Yver, Head of Oncology at AstraZeneca.

Olaparib has already been approved by regulatory authorities in 40 countries as maintenance treatment of women with BRCA-mutated ovarian cancer.


  1. Lynparza™ (olaparib) granted Breakthrough Therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer [news release]. AstraZeneca. January 28, 2016. Accessed February 1, 2016.