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FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC.

Autor: Akinboro O; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Larkins E; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Pai-Scherf LH; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Mathieu LN; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Ren Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Cheng J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Fu W; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Bi Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Kalavar S; Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Jafri S; Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Mishra-Kalyani PS; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Fourie Zirkelbach J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Li H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Zhao H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., He K; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Helms WS; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Chuk MK; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Wang M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Bulatao I; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Herz J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Osborn BL; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Xu Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Liu J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Gong Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Sickafuse S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Cohen R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Donoghue M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Singh H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Jun 01; Vol. 28 (11), pp. 2221-2228.

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.

Autor: Theoret MR; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Marc.Theoret@fda.hhs.gov., Pai-Scherf LH; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chuk MK; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Prowell TM; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Balasubramaniam S; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kim T; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kim G; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Keegan P; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2015 Oct 15; Vol. 21 (20), pp. 4545-51.