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FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma.
Patel, Timil H; Brewer, Jamie R; Fan, Jiaxin; Cheng, Joyce; Shen, Yuan-Li; Xiang, Yue; Zhao, Hong; Lemery, Steven J; Pazdur, Richard; Kluetz, Paul G; Fashoyin-Aje, Lola A.
  • Patel TH; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Brewer JR; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fan J; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Cheng J; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shen YL; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Xiang Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao H; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lemery SJ; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fashoyin-Aje LA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 30(2): 269-273, 2024 01 17.
Article en En | MEDLINE | ID: mdl-37676259

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma Hepatocelular / Anticuerpos Monoclonales Humanizados / Neoplasias Hepáticas / Anticuerpos Monoclonales Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Año: 2024 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma Hepatocelular / Anticuerpos Monoclonales Humanizados / Neoplasias Hepáticas / Anticuerpos Monoclonales Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Año: 2024 Tipo del documento: Article