FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline <i>BRCA</i>-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

Geoffrey Kim(United States Food and Drug Administration), Gwynn Ison(United States Food and Drug Administration), Amy E. McKee(United States Food and Drug Administration), Hui Zhang(United States Food and Drug Administration), Shenghui Tang(United States Food and Drug Administration), Thomas Gwise(United States Food and Drug Administration), Rajeshwari Sridhara(United States Food and Drug Administration), Eunice Lee(Center for Devices and Radiological Health), Abraham Tzou(Center for Devices and Radiological Health), Reena Philip(Center for Devices and Radiological Health), Haw-Jyh Chiu(United States Food and Drug Administration), Tiffany K. Ricks(United States Food and Drug Administration), Todd R. Palmby(United States Food and Drug Administration), Anne‐Marie Russell(Center for Drug Evaluation and Research), Gaétan Ladouceur(Center for Drug Evaluation and Research), Elimika Pfuma(United States Food and Drug Administration), Hongshan Li(United States Food and Drug Administration), Liang Zhao(United States Food and Drug Administration), Qi Liu(United States Food and Drug Administration), Rajesh Venugopal(United States Food and Drug Administration), Amna Ibrahim(United States Food and Drug Administration), Richard Pazdur(United States Food and Drug Administration)
Clinical Cancer Research
July 18, 2015
10.1158/1078-0432.ccr-15-0887
Cited by 526

Abstract

On December 19, 2014, the FDA approved olaparib capsules (Lynparza; AstraZeneca) for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.) was approved concurrently. An international multicenter, single-arm trial enrolled 137 patients with measurable gBRCAm-associated ovarian cancer treated with three or more prior lines of chemotherapy. Patients received olaparib at a dose of 400 mg by mouth twice daily until disease progression or unacceptable toxicity. The objective response rate (ORR) was 34% with median response duration of 7.9 months in this cohort. The most common adverse reactions (≥20%) in patients treated with olaparib were anemia, nausea, fatigue (including asthenia), vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis/pharyngitis/upper respiratory infection, cough, arthralgia/musculoskeletal pain, myalgia, back pain, dermatitis/rash, and abdominal pain/discomfort. Myelodysplatic syndrome and/or acute myeloid leukemia occurred in 2% of the patients enrolled on this trial.

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