{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T14:18:07Z","timestamp":1770041887226,"version":"3.49.0"},"reference-count":8,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2017,6,19]],"date-time":"2017-06-19T00:00:00Z","timestamp":1497830400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2017,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The U.S. Food and Drug Administration (FDA) approved eltrombopag for pediatric patients with chronic immune (idiopathic) thrombocytopenia (ITP) ages \u22656 on June 11, 2015, and ages \u22651 on August 24, 2015. Approval was based on the FDA review of two randomized trials that included 159 pediatric patients with chronic ITP who had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. This manuscript describes the basis for approval of these applications. The FDA concluded that eltrombopag has shown efficacy and a favorable benefit to risk profile for pediatric patients with chronic ITP.<\/jats:p>","DOI":"10.1002\/pbc.26657","type":"journal-article","created":{"date-parts":[[2017,6,19]],"date-time":"2017-06-19T08:31:21Z","timestamp":1497861081000},"source":"Crossref","is-referenced-by-count":15,"title":["U.S. Food and Drug Administration approval summary: Eltrombopag for the treatment of pediatric patients with chronic immune (idiopathic) thrombocytopenia"],"prefix":"10.1002","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5981-1332","authenticated-orcid":false,"given":"Lori A.","family":"Ehrlich","sequence":"first","affiliation":[{"name":"Office of Hematology and Oncology Products Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia E.","family":"Kwitkowski","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory","family":"Reaman","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chia\u2010Wen","family":"Ko","sequence":"additional","affiliation":[{"name":"Office of Biostatistics Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lei","family":"Nie","sequence":"additional","affiliation":[{"name":"Office of Biostatistics Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Pazdur","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann T.","family":"Farrell","sequence":"additional","affiliation":[{"name":"Office of Hematology and Oncology Products Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,6,19]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/asheducation-2006.1.97"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.21616"},{"issue":"3","key":"e_1_2_10_4_1","first-page":"221","article-title":"Management of immune thrombocytopenic purpura: an update","volume":"12","author":"Warrier R","year":"2012","journal-title":"Ochsner J"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2008-07-162503"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12813"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3026(15)00114-3"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)61107-2"},{"key":"e_1_2_10_9_1","unstructured":"FDA Promacta Prescribing Information. 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