FDA Guidance on Treatments for Renal Cell Carcinoma

FDA published guidance on October 1, 2020 regarding the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma. Eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival (DFS), and interpretation of trial results are discussed in the guidance document. According to FDA, the guidance is focused on clinical trials with DFS as the primary efficacy endpoint.

The guidance states that, “Significant variability exists in the design, conduct, and analysis of trials for the adjuvant treatment of renal cell carcinoma, including the eligibility criteria, radiological disease assessments, the definition of disease recurrence, and the date used to define the DFS endpoint. Consistency in these aspects within and across trials may facilitate interpretation of trial results.”