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Review
. 2022 Mar 15;28(6):1058-1071.
doi: 10.1158/1078-0432.CCR-21-2599.

U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review

Shaily Arora  1 , Preeti Narayan  1 , Gwynn Ison  1 , Tara Berman  1 , Daniel L Suzman  1 , Suparna Wedam  1 , Tatiana M Prowell  1 , Soma Ghosh  2 , Reena Philip  2 , Christy L Osgood  1 , Jennifer J Gao  3 , Mirat Shah  1 , Danielle Krol  1 , Sakar Wahby  1 , Melanie Royce  1 , Christina Brus  1 , Erik W Bloomquist  1 , Mallorie H Fiero  1 , Shenghui Tang  1 , Richard Pazdur  3 , Amna Ibrahim  1 , Laleh Amiri-Kordestani  1 , Julia A Beaver  1   3
Affiliations
Review

U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review

Shaily Arora et al. Clin Cancer Res. .

Abstract

Over the last decade, there has been tremendous progress in the treatment of patients with gynecologic cancers with a changing therapy landscape. This summary provides an overview of U.S. Food and Drug Administration (FDA) approvals for gynecologic cancers from 2010 to 2020, totaling 17 new indications. For each of the approved indications, endpoints, trial design, results, and regulatory considerations are outlined. Among these 17 indications, six received accelerated approval (AA) and 11 received regular approval (RA). As of September 2021, of the six AA, three have subsequently demonstrated clinical benefit resulting in conversion to RA and the remaining three have ongoing clinical trials that have not yet reported results. Approval decisions for these 17 indications were supported by primary efficacy endpoints of progression-free survival (n = 10), objective response rate (n = 6), and overall survival (n = 1) and showed a favorable benefit-risk profile. Among the 17 indications, 15 received priority review and three applications participated in one or more novel Oncology Center of Excellence initiatives, including Real Time Oncology Review, Assessment Aid, and Project Orbis. Current FDA thinking on drug development opportunities and regulatory initiatives currently under way will be discussed.

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Conflict of interest statement

Disclosure of Potential Conflicts of Interest: The authors report no financial interests or relationships with the commercial sponsors of any products discussed in this report.

Figures

Figure 1:
Figure 1:. FDA Approvals in Gynecologic Malignancies: 2010-2020,
(Figure represents indication granted at time of approval.)
See this image and copyright information in PMC

References

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