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

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🔗 View Article (PMID 26187614)

Published in Clin Cancer Res on July 17, 2015

Authors

Geoffrey Kim1, Gwynn Ison2, Amy E McKee2, Hui Zhang3, Shenghui Tang3, Thomas Gwise3, Rajeshwari Sridhara3, Eunice Lee4, Abraham Tzou4, Reena Philip4, Haw-Jyh Chiu2, Tiffany K Ricks2, Todd Palmby2, Anne Marie Russell5, Gaetan Ladouceur5, Elimika Pfuma6, Hongshan Li6, Liang Zhao6, Qi Liu6, Rajesh Venugopal2, Amna Ibrahim2, Richard Pazdur2

Author Affiliations

1: Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland. Geoffrey.Kim@fda.hhs.gov.
2: Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
3: Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
4: Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
5: New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
6: Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.

Associated clinical trials:

Bortezomib and Pegylated Liposomal Doxorubicin in BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer Patients | NCT03509246

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