FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial.

Pulte, E Dianne; Chen, Haiyan; Price, Lauren S L; Gudi, Ramadevi; Li, Hongshan; Okusanya, Olanrewaju O; Ma, Lian; Rodriguez, Lisa; Vallejo, Jonathon; Norsworthy, Kelly J; de Claro, R Angelo; Theoret, Marc R; Pazdur, Richard

Pulte, E Dianne; Chen, Haiyan; Price, Lauren S L; Gudi, Ramadevi; Li, Hongshan; Okusanya, Olanrewaju O; Ma, Lian; Rodriguez, Lisa; Vallejo, Jonathon; Norsworthy, Kelly J; de Claro, R Angelo; Theoret, Marc R; Pazdur, Richard.

Afiliação

Pulte ED; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Chen H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Price LSL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Gudi R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Li H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Okusanya OO; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Rodriguez L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Oncologist ; 27(2): 149-157, 2022 03 04.

Article em En | MEDLINE | ID: mdl-35641211

Assuntos

Antineoplásicos; Leucemia Mielogênica Crônica BCR-ABL Positiva; Idoso; Antineoplásicos/efeitos adversos; Resistencia a Medicamentos Antineoplásicos/genética; Proteínas de Fusão bcr-abl/genética; Humanos; Imidazóis; Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico; Leucemia Mielogênica Crônica BCR-ABL Positiva/genética; Inibidores de Proteínas Quinases/efeitos adversos; Piridazinas; Estados Unidos; United States Food and Drug Administration

Palavras-chave

FDA approval; chronic-phase chronic myeloid leukemia; ponatinib

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Leucemia Mielogênica Crônica BCR-ABL Positiva / Antineoplásicos Tipo de estudo: Clinical_trials / Prognostic_studies / Risk_factors_studies Limite: Aged / Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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