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FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
Przepiorka, Donna; Le, Robert Q; Ionan, Alexei; Li, Ruo-Jing; Wang, Ying-Hong; Gudi, Ramadevi; Mitra, Soumya; Vallejo, Jonathon; Okusanya, Olanrewaju O; Ma, Lian; Yang, Yuching; Patel, Paresma; Mezaache, Djelila; Shah, Rakhi; Banerjee, Anamitro; McLamore, Sherita; Maung, Adam N; Goldberg, Kirsten B; Pazdur, Richard; Theoret, Marc R; De Claro, R Angelo.
Afiliação
  • Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Le RQ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ionan A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li RJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Wang YH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gudi R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mitra S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Okusanya OO; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Yang Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Patel P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mezaache D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shah R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Banerjee A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • McLamore S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Maung AN; Oncology Center of Excellence Summer Scholars Program, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • De Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 28(12): 2488-2492, 2022 06 13.
Article em En | MEDLINE | ID: mdl-35135839

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Etiology_studies Limite: Adult / Child / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Etiology_studies Limite: Adult / Child / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article