FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
Top Cited Papers
- 30 September 2015
- journal article
- review article
- Published by American Association for Cancer Research (AACR) in Clinical Cancer Research
- Vol. 21 (19), 4257-4261
- https://doi.org/10.1158/1078-0432.ccr-15-0887
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. Clin Cancer Res; 21(19); 4257–61. ©2015 AACR.Keywords
This publication has 19 references indexed in Scilit:
- BRCA Mutation Frequency and Patterns of Treatment Response in BRCA Mutation–Positive Women With Ovarian Cancer: A Report From the Australian Ovarian Cancer Study GroupJournal of Clinical Oncology, 2012
- Olaparib Maintenance Therapy in Platinum-Sensitive Relapsed Ovarian CancerThe New England Journal of Medicine, 2012
- Frequencies of BRCA1 and BRCA2 mutations among 1,342 unselected patients with invasive ovarian cancerGynecologic Oncology, 2011
- Usefulness of third-line chemotherapy for women with recurrent ovarian, fallopian tube, and primary peritoneal cancer who receive platinum/taxane regimens as first-line therapyZeitschrift für Krebsforschung und Klinische Onkologie, 2008
- Effect of BRCA1/2 Mutations on Long-Term Survival of Patients With Invasive Ovarian Cancer: The National Israeli Study of Ovarian CancerJournal of Clinical Oncology, 2008
- The BRCA1/2 pathway prevents hematologic cancers in addition to breast and ovarian cancersBMC Cancer, 2007
- BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma casesCancer, 2005
- Third-line chemotherapy in platinum- and paclitaxel-resistant ovarian, fallopian tube, and primary peritoneal carcinoma patientsInternational Journal of Gynecologic Cancer, 2004
- The Fanconi anaemia/BRCA pathwayNature Reviews Cancer, 2003
- Identification of the breast cancer susceptibility gene BRCA2Nature, 1995