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October 09, 2020

FDA Issues Draft Guidances to Facilitate Adjuvant Treatment Development for Kidney and Bladder Cancer

On October 2, the FDA issued draft guidelines for researchers as they pursue efforts to develop drugs to treat renal cell and bladder cancers. Both the renal draft guidance as well as the bladder cancer draft guidance  are meant to provide recommendations to sponsors regarding the development of drugs and biologics for the adjuvant treatment of these two cancer types. The end goal of these guidance documents is to assist researchers with recommendations on trial eligibility criteria, standardized imaging assessments, and determining disease recurrence which would allow for improved interpretation of trial results for those patients enrolled in clinical trials.

Currently, there is significant variability in the design, conduct, and analysis of clinical trials for adjuvant treatment of both kidney cancer and bladder cancer. This variability negatively affects our ability to interpret trial results," said Richard Pazdur, acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

The deadline for public comment on the draft guidance is December 1.