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FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.
Dilawari, Asma; Shah, Mirat; Ison, Gwynn; Gittleman, Haley; Fiero, Mallorie H; Shah, Ankit; Hamed, Salaheldin S; Qiu, Junshan; Yu, Jingyu; Manheng, Wimolnut; Ricks, Tiffany K; Pragani, Rajan; Arudchandran, Arulvathani; Patel, Paresma; Zaman, Shadia; Roy, Arpita; Kalavar, Shyam; Ghosh, Soma; Pierce, William F; Rahman, Nam Atiqur; Tang, Shenghui; Mixter, Bronwyn D; Kluetz, Paul G; Pazdur, Richard; Amiri-Kordestani, Laleh.
Afiliação
  • Dilawari A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shah M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ison G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gittleman H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shah A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Hamed SS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Qiu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Manheng W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pragani R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Arudchandran A; 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.
  • Zaman S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Roy A; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kalavar S; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ghosh S; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rahman NA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mixter BD; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; 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.
  • Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 29(19): 3835-3840, 2023 10 02.
Article em En | MEDLINE | ID: mdl-37212825
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Imunoconjugados Tipo de estudo: Clinical_trials / Risk_factors_studies Limite: Adult / Female / Humans Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2023 Tipo de documento: Article País de publicação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Imunoconjugados Tipo de estudo: Clinical_trials / Risk_factors_studies Limite: Adult / Female / Humans Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2023 Tipo de documento: Article País de publicação: Estados Unidos