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FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.
Kim, Geoffrey; Ison, Gwynn; McKee, Amy E; Zhang, Hui; Tang, Shenghui; Gwise, Thomas; Sridhara, Rajeshwari; Lee, Eunice; Tzou, Abraham; Philip, Reena; Chiu, Haw-Jyh; Ricks, Tiffany K; Palmby, Todd; Russell, Anne Marie; Ladouceur, Gaetan; Pfuma, Elimika; Li, Hongshan; Zhao, Liang; Liu, Qi; Venugopal, Rajesh; Ibrahim, Amna; Pazdur, Richard.
  • Kim G; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland. Geoffrey.Kim@fda.hhs.gov.
  • Ison G; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • McKee AE; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhang H; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Tang S; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gwise T; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sridhara R; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lee E; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Tzou A; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Philip R; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chiu HJ; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ricks TK; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Palmby T; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Russell AM; New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ladouceur G; New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pfuma E; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li H; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao L; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Liu Q; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Venugopal R; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ibrahim A; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 21(19): 4257-61, 2015 Oct 01.
Article en En | MEDLINE | ID: mdl-26187614
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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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Ftalazinas / Piperazinas / United States Food and Drug Administration / Aprobación de Drogas / Mutación de Línea Germinal / Genes BRCA1 / Genes BRCA2 / Antineoplásicos Límite: Animals / Female / Humans País como asunto: America do norte Idioma: En Año: 2015 Tipo del documento: Article
Texto completo
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Ftalazinas / Piperazinas / United States Food and Drug Administration / Aprobación de Drogas / Mutación de Línea Germinal / Genes BRCA1 / Genes BRCA2 / Antineoplásicos Límite: Animals / Female / Humans País como asunto: America do norte Idioma: En Año: 2015 Tipo del documento: Article