Journal
CANCER
Volume 123, Issue 14, Pages 2604-2608Publisher
WILEY
DOI: 10.1002/cncr.30652
Keywords
bevacizumab; drug approval; drug development; drug regulation; olaparib; ovarian cancer; US Food and Drug Administration (FDA)
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Funding
- US federal government
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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. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.
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