FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors.

Marcus, Leigh; Fashoyin-Aje, Lola A; Donoghue, Martha; Yuan, Mengdie; Rodriguez, Lisa; Gallagher, Pamela S; Philip, Reena; Ghosh, Soma; Theoret, Marc R; Beaver, Julia A; Pazdur, Richard; Lemery, Steven J

Marcus, Leigh; Fashoyin-Aje, Lola A; Donoghue, Martha; Yuan, Mengdie; Rodriguez, Lisa; Gallagher, Pamela S; Philip, Reena; Ghosh, Soma; Theoret, Marc R; Beaver, Julia A; Pazdur, Richard; Lemery, Steven J.

Afiliação

Marcus L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Leigh.Marcus@fda.hhs.gov.
Fashoyin-Aje LA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Donoghue M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Yuan M; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Administration, Silver Spring, Maryland.
Rodriguez L; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Administration, Silver Spring, Maryland.
Gallagher PS; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Philip R; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Ghosh S; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Pazdur R; Oncology Center of Excellence, 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.

Clin Cancer Res ; 27(17): 4685-4689, 2021 09 01.

Article em En | MEDLINE | ID: mdl-34083238

Assuntos

Anticorpos Monoclonais Humanizados/genética; Anticorpos Monoclonais Humanizados/uso terapêutico; Antineoplásicos Imunológicos/uso terapêutico; Aprovação de Drogas; Mutação; Neoplasias/tratamento farmacológico; Neoplasias/genética; Adulto; Criança; Humanos; Estudos Retrospectivos; Estados Unidos

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aprovação de Drogas / Anticorpos Monoclonais Humanizados / Antineoplásicos Imunológicos / Mutação / Neoplasias Tipo de estudo: Observational_studies Limite: Adult / Child / Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2021 Tipo de documento: Article

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