Trends in FDA approvals of gynecologic oncology therapeutics from 2019 to 2024

Abstract

Objective

To quantify the impact of Food and Drug Administration (FDA) therapeutic approvals in gynecologic oncology from 2019 to 2024 and compare these approvals to other solid tumor disease sites.

Methods

The FDA Approval Notifications was evaluated to assess drug approvals for solid tumors between August 15, 2019 and August 15, 2024. Drug approvals were evaluated to determine if they replaced the current standard of care (SOC), were used in combination with currently approved drugs, were used for adjuvant or maintenance therapy, or were approved for recurrence. Average therapeutic approval growth for each solid tumor category was calculated using the slope (b) from a simple linear regression model. Statistics were performed via Prism v10.1.1.

Results

There were 150 drug approvals for solid tumors with gynecologic cancers representing 9.3 %. Gynecologic oncology had the second highest number of drug approvals compared to all other solid tumor disease sites. Of these, 8 were add on therapies (57.1 %) and 6 were later line therapies (42.9 %). Most disease sites (61.0 %) experienced an average decrease in FDA drug approvals during the study period. However, gynecologic oncology had the third largest approval growth (b = 0.17) compared to all other solid tumors.

Conclusion

While only representing 5 % of the oncology field, gynecologic oncology held the second highest number of FDA approvals by disease site in solid tumors (Ackroyd et al., 2021 [1]). The add on therapies provide a significant benefit in progression free and overall survival in the frontline setting and the later line therapies offer promising response rates in a heavily pre-treated population. This study highlights the promising future of gynecologic oncology therapeutics given the third largest relative growth in drug approvals compared to all other solid tumors.