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FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAFV600 Mutation.
Oneal, Patricia A; Kwitkowski, Virginia; Luo, Lola; Shen, Yuan Li; Subramaniam, Sriram; Shord, Stacy; Goldberg, Kirsten B; McKee, Amy E; Kaminskas, Edvardas; Farrell, Ann; Pazdur, Richard.
Affiliation
  • Oneal PA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA patricia.oneal@fda.hhs.gov.
  • Kwitkowski V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Luo L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Shen YL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Subramaniam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Shord S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • McKee AE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kaminskas E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Farrell A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Oncologist ; 23(12): 1520-1524, 2018 12.
Article in En | MEDLINE | ID: mdl-30120160
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Erdheim-Chester Disease / Proto-Oncogene Proteins B-raf / Vemurafenib / Antineoplastic Agents Type of study: Clinical_trials / Observational_studies Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Oncologist Year: 2018 Document type: Article
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Erdheim-Chester Disease / Proto-Oncogene Proteins B-raf / Vemurafenib / Antineoplastic Agents Type of study: Clinical_trials / Observational_studies Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Oncologist Year: 2018 Document type: Article