GUIDANCE DOCUMENT
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment Draft Guidance for Industry October 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-D-1497
- Issued by:
-
Guidance Issuing OfficeOncology Center of ExcellenceCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance provides recommendations to sponsors regarding the development of drugs and biologics, regulated by CDER and CBER for the adjuvant treatment of muscle-invasive bladder cancer. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival (DFS), and interpretation of trial results. Although FDA may consider endpoints other than DFS for the adjuvant treatment of muscle-invasive bladder cancer, this guidance is focused on clinical trials with DFS as the primary efficacy endpoint.
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