FDA Oncology Approvals (OCE) & Novel Drug Approvals
The FDA's oncology approval notifications are the official record of what is approved for what.
Also see the AACR quarterly digest and Project Orbis for international concurrent review.
Pages like this
not linked directly; found by shared links- CollectionESMO Clinical Practice Guidelines & MCBS
Shares Weak real-world evidence and registries, Regulatory divergence between regions, Incentives reward me-too drugs and marginal gains, Prices and value.
- TermAccelerated approval
Shares Conditional approvals that lapse automatically if the confirmatory trial is late, A public registry of cancer treatments that were later shown not to work, FDA Oncology Center of Excellence, Weak real-world evidence and registries.
- CollectionDrugBank & ChEMBL
Shares Every approved cancer drug ships with a public combination-readiness data pack, Require every oncology candidate to publish how much reaches the brain.
- IdeaA mandatory over-70s cohort with geriatric assessment in every pivotal trial
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses, Trials do not represent the people who get cancer.
- BottleneckKnowledge reaches practice too slowly
Shares A 'dose evidence' panel in every label: how many doses were tested, and how, A public index of how the same cancer drug's label differs between countries, Print the participation-to-prevalence ratio in every drug label and assessment report, A public registry of cancer treatments that were later shown not to work.
- IdeaRequire post-approval evidence in patients over 75 and update labels accordingly
Shares Older and multimorbid patients are excluded and undertreated, Weak real-world evidence and registries, Regulatory divergence between regions.
- IdeaMandatory real-world reporting for patients excluded from pivotal trials
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer, Weak real-world evidence and registries.
- IdeaMake sponsors justify every trial exclusion of older and multimorbid patients
Shares Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer, Trial design, endpoints and cost.