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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements.
Gandhy, Shruti U; Casak, Sandra J; Mushti, Sirisha L; Cheng, Joyce; Subramaniam, Sriram; Zhao, Hong; Zhao, Miao; Bi, Youwei; Liu, Guansheng; Fan, Jianghong; Adeniyi, Oluseyi; Charlab, Rosane; Kufrin, Dubravka; Thompson, Matthew D; Jarrell, Kristin; Auth, Doris; Lemery, Steven J; Pazdur, Richard; Kluetz, Paul G; Fashoyin-Aje, Lola A.
Afiliação
  • Gandhy SU; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Casak SJ; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Mushti SL; Office of Biostatistics, Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, Maryland.
  • Cheng J; Office of Biostatistics, Office of Translational Sciences (OTS), CDER, U.S. FDA, Silver Spring, Maryland.
  • Subramaniam S; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Zhao H; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Zhao M; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Bi Y; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Liu G; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Fan J; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Adeniyi O; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Charlab R; Office of Clinical Pharmacology, OTS, CDER, U.S. FDA, Silver Spring, Maryland.
  • Kufrin D; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Thompson MD; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Jarrell K; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Auth D; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Lemery SJ; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Kluetz PG; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
  • Fashoyin-Aje LA; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
Clin Cancer Res ; 29(20): 4027-4031, 2023 Oct 13.
Article em En | MEDLINE | ID: mdl-37289037
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pirazóis / Pirróis / Neoplasias dos Ductos Biliares / Colangiocarcinoma Tipo de estudo: Clinical_trials Limite: Adult / Humans Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pirazóis / Pirróis / Neoplasias dos Ductos Biliares / Colangiocarcinoma Tipo de estudo: Clinical_trials Limite: Adult / Humans Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2023 Tipo de documento: Article