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

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.

Deregulated Metabolic Pathways in Ovarian Cancer: Cause and Consequence

“…This proves that identifying a proper therapeutic agent that effectively targets ovarian cancer is a difficult task. Recently, FDA has approved a list of drugs for the treatment of ovarian cancer, and some of the promising drugs such as metformin which effectively targets glucose metabolism are still in the clinical trials [284,285]. The role of the approved drugs in targeting the metabolism in ovarian cancer is yet to be understood clearly and developing new drugs that target the ovarian cancer metabolism can be a promising treatment modality.…”

Ovarian Recurrence risk Assessment using Clinical and serum protein LEvels (ORACLE): A Machine Learning Risk Score to Predict Survival in High Grade Ovarian Cancer

“…Ovarian cancer continues to be the most lethal gynecologic malignancy despite having the most new FDA approved medications over the last 10 years compared to cervical and endometrial cancer [1,11]. While most research have focused on tumor biology at diagnosis to predict recurrence and potential new treatments, few have tried to monitor microscopic residual disease at the time of a complete response via serum biomarkers.…”

Pore-engineered nanoarchitectonics for cancer therapy

“…A wide array of mesoporous inorganic, organic and organic-inorganic hybrid structures have been proposed for industrial, biomedical, sensor, and new energy applications [60][61][62][63][64][65] . However, in terms of the cancer field, only a few of them can be employed.…”