Regulatory considerations on endpoints in ovarian cancer drug development.
Cancer
; 123(14): 2604-2608, 2017 Jul 15.
Article
em En
| MEDLINE
| ID: mdl-28499075
ABSTRACT
Ovarian cancer remains a disease entity that is responsible for considerable morbidity and mortality among women worldwide. Modern drug research pipelines and accelerated drug development timelines applied to other disease entities have begun to make an impact on treatment options for patients with advanced ovarian cancer, as exemplified by the recent accelerated approval of 2 agents for this disease as the forerunners of a growing number of registrational trials. Regulatory flexibility for this serious and life-threatening condition spurs the consideration of intermediate endpoints for regulatory trial design, including potential applications in the development of newer therapeutic classes such as targeted therapies and immunotherapies for patients with advanced ovarian cancer. Cancer 2017;1232604-8. © 2017 American Cancer Society.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Ovarianas
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Ftalazinas
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Piperazinas
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Aprovação de Drogas
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Inibidores da Angiogênese
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Bevacizumab
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Antineoplásicos
Tipo de estudo:
Prognostic_studies
Limite:
Female
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Cancer
Ano de publicação:
2017
Tipo de documento:
Article