Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment." This guidance is intended to facilitate the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma and provides recommendations for the sponsor on this topic. The guidance includes recommendations regarding eligibility criteria, choice of comparator, followup imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. This guidance finalizes the draft guidance of the same title issued on October 2, 2020.