ArticleClinical cancer research : an official journal of the American Association for Cancer Research2024
An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012-2022.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed, 15 citations in OpenAlex.
- Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now?Therapeutic innovation & regulatory science · 2026Article
- Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.Pharmaceutical medicine · 2026Article
- Feasibility assessment of an EHR-integrated research platform for prospective data collection in community oncology practice.npj health systems · 2026Article
- FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early-Phase Trials Using Innovative Trial Designs and Biomarkers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Article
- Improving the Dosing Schedules of Targeted Anticancer Agents.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years.Clinical pharmacology and therapeutics · 2025Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
The FDA's Oncology Center of Excellence's (OCE) launch of Project Optimus signals increased focus on dose optimization approaches in oncology drug development, particularly toward optimization in the premarket setting. Although sponsors continue to adapt premarket study designs and approaches to align with FDA's expectations for dose optimization, including consideration of the optimal dosage(s), there are still instances where questions remain at the time of approval about whether the approved doses or schedules are optimal. In these cases, FDA can exercise regulatory flexibility by issuing postmarketing requirements (PMR) and avoid delaying patient access to promising therapies. This landscape analysis demonstrates that over the past decade (2012-2022), FDA frequently used PMRs to answer additional questions about dosing for novel oncology approvals. We found more than half of drugs (78/132, 59.1%) had a dosing PMR and observed a recent increase in PMRs intended to evaluate whether a lower dose could be more optimal. These results suggest there are opportunities to adapt premarket dose optimization strategies and leverage innovative development tools to ensure timely identification of the optimal dose.
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.