FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
Cet article présente les données ayant servi de base à la "Food and Drug Administration" pour autoriser la mise sur le marché de l'olaparib dans le traitement des patientes atteintes d'un cancer avancé de l'ovaire présentant des mutations constitutionnelles d'un gène BRCA
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 daily until disease progression or unacceptable toxicity. The overall 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/URI, 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.