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Regulatory considerations on endpoints in ovarian cancer drug development
Author(s) -
Balasubramaniam Sanjeeve,
Kim Geoffrey S.,
McKee Amy E.,
Pazdur Richard
Publication year - 2017
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.30652
Subject(s) - medicine , ovarian cancer , drug development , disease , cancer , cancer drugs , drug , clinical trial , timeline , intensive care medicine , drug approval , oncology , pharmacology , archaeology , history
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;123:2604‐8 . © 2017 American Cancer Society .