Regulatory Considerations on Endpoints in Ovarian Cancer Drug Development

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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.

Recent approvals by the US Food and Drug Administration of agents for the treatment of patients with advanced ovarian cancer herald a new era in ovarian cancer treatment options. Regulatory insights regarding endpoints for future drug development pathways, including molecularly targeted therapies and immunotherapies, are discussed.

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