FDA validation of surrogate endpoints in oncology: 2005–2022

FDA drug approval, surrogate endpoints, oncology drugs, overall survival correlation, clinical trials analysis, drug approval guidelines

ere are summary bullets based on the provided text: The FDA has increasingly approved oncologic drugs based on surrogate endpoints, which often lack a demonstrated correlation with clinically meaningful outcomes like overall survival. A review of FDA analyses from 2005 to 2022 examined the valid…

Dec 1^st • 20 mins read

Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology

monoclonal antibodies, E-R analyses, tumour growth inhibition, drug development

Dose selection and optimization is crucial in drug development to maximize benefits for all patients. Exposure–response (E-R) analysis is useful for dose-selection strategy, but in oncology, prognostic factors can confound the analysis, especially for monoclonal antibodies. The review addr…

Nov 20^th • 12 mins read

Clinical benefit of cancer drugs approved in Switzerland 2010–2019

cancer drug approval, clinical benefit criteria, ESMO-MCBS, ASCO-VF, OLUtool, Switzerland oncology drugs

The study evaluates the clinical benefit of cancer drugs approved in Switzerland between 2010 and 2019 using three different frameworks: ESMO-MCBS, ASCO-VF, and OLUtool. A total of 48 drugs for 92 indications were assessed based on 100 studies, with each study evaluated according to the criteria …

Jun 10^th • 35 mins read

FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019

FDA, Surrogate End Points, Cancer drug approval

194 approvals were analyzed, with 64 (32.9%) relying on surrogate endpoints for the first time in a specific cancer type. Surrogate endpoints often have weak or unknown correlations to overall survival (OS). Many approvals lack strong scientific or regulatory justification, indicating a higher t…

Mar 9^th • 4 mins read