Issue Date: June 27, 2022
Issued by: Oncology Center of Excellence
Topic(s): Premarket, Clinical – Medical
Status: Final
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for Industry
This guidance provides recommendations to sponsors regarding the development of drugs and biological products regulated by CDER and CBER for the adjuvant treatment of renal cell carcinoma. 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 renal cell carcinoma, this guidance is focused on clinical trials with DFS as the primary efficacy endpoint.
Download the Guidance Document
