• Stephanie Lheureux, Valerie Bowering, Katherine Karakasis, and Amit M Oza.
• University of Toronto, Princess Margaret Cancer Centre, Division of Medical Oncology and Hematology, Drug Development Program , 610 University Avenue, Toronto, Ontario , Canada.
• Expert Opin Drug Saf. 2015 Aug 1; 14 (8): 1305-16.

IntroductionOlaparib (Lynparza®) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor that has become the first 'personalized' therapy available for patients with BRCA mutation-positive ovarian cancer (OC). A capsule formulation of the drug has recently received approval for use in this population for platinum-sensitive recurrent disease for maintenance therapy following platinum-based chemotherapy in Europe and as third- or fourth-line platinum-sensitive therapy in the USA.Areas CoveredThis article reviews the development of olaparib in OC with a focus on safety evaluation. Data are based on published literature and reports available from the olaparib development program database.Expert OpinionOral olaparib 400 mg twice daily has acceptable tolerability when administered as maintenance monochemotherapy in women with relapsed OC. The common toxicities - nausea/vomiting, fatigue and anemia - are mild or moderate in severity and appear consistent across subgroups (BRCA carriers/wild-type). Though the risk is low, long-term monitoring of patients is warranted to determine the potential risk for hematological complications such as anemia, myelodysplastic syndrome or acute myeloid leukemia.

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