ReviewClinical cancer research : an official journal of the American Association for Cancer Research2022
U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review.
Review in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Durvalumab and cediranib with and without olaparib in recurrent ovarian cancer: a phase II proof-of-concept study.Nature communications · 2026Trial
- Small but mighty: Peptides as next-generation immunotargeting agents in gynecological cancers.Translational oncology · 2026Review
- Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part I-Coordinated Registry Networks and Systemic Coordinated Inter-Organizational Networks.International journal of translational medical research and public health · 2025Article
- Characteristics and potential predictors of prematurely terminated interventional clinical trials for ovarian cancer in the ClinicalTrials.gov database.BMC cancer · 2025Article
- Phase II proof-of-concept study of durvalumab and cediranib with and without olaparib in recurrent ovarian cancer.Research square · 2025Article
- Detecting vascular normalization in epithelial ovarian cancer.Medical oncology (Northwood, London, England) · 2025Review
- Clinical efficacy of plasmid encoding p62/SQSTM1 (Elenagen) in combination with gemcitabine in patients with platinum-resistant ovarian cancer: a randomized controlled trial.Frontiers in oncology · 2024Article
- Ovarian recurrence risk assessment using machine learning, clinical information, and serum protein levels to predict survival in high grade ovarian cancer.Scientific reports · 2023Article
- Timing and Reporting of Secondary Overall Survival End Points for Phase III Trials in Advanced/Metastatic Disease.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Review
- The importance of molecular classification of endometrial carcinomas in clinical practice: how to apply it and difficulties in applicationJournal of the Turkish German Gynecological Association · 2023Article
- Deregulated Metabolic Pathways in Ovarian Cancer: Cause and Consequence.Metabolites · 2023Review
- Encouraging Rigorous Patient-Generated Data All Along the Drug Development Continuum.Journal of the National Cancer Institute · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors.
Funding
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.