Dinkins Kaitlyn G, Lee Grace M, Arend Rebecca C, Leath Charles A, Toboni Michael D
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, O'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, United States of America.
Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL, United States of America.
Gynecol Oncol. 2025 Mar;194:153-158. doi: 10.1016/j.ygyno.2025.03.010.
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.
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.
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.
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.
量化2019年至2024年美国食品药品监督管理局（FDA）在妇科肿瘤学治疗批准方面的影响，并将这些批准与其他实体瘤疾病部位进行比较。
评估FDA批准通知，以评估2019年8月15日至2024年8月15日期间实体瘤的药物批准情况。评估药物批准情况，以确定它们是否取代了当前的标准治疗（SOC）、是否与当前批准的药物联合使用、是否用于辅助或维持治疗，或是否被批准用于复发治疗。使用简单线性回归模型的斜率（b）计算每个实体瘤类别的平均治疗批准增长率。通过Prism v10.1.1进行统计分析。
有150项实体瘤药物批准，其中妇科癌症占9.3%。与所有其他实体瘤疾病部位相比，妇科肿瘤学的药物批准数量排名第二高。其中，8项为附加疗法（57.1%），6项为后续线治疗（42.9%）。在研究期间，大多数疾病部位（61.0%）的FDA药物批准数量平均有所下降。然而，与所有其他实体瘤相比，妇科肿瘤学的批准增长幅度排名第三大（b = 0.17）。
虽然妇科肿瘤学仅占肿瘤学领域的5%，但在实体瘤中，按疾病部位计算，其获得FDA批准的数量排名第二高（Ackroyd等人，2021年[1]）。附加疗法在一线治疗中对无进展生存期和总生存期有显著益处，而后续线治疗在经过大量预处理的人群中显示出有希望的缓解率。鉴于与所有其他实体瘤相比，药物批准的相对增长幅度排名第三大，本研究突出了妇科肿瘤学治疗的光明前景。
