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FDA In Brief: FDA Issues Two Draft Guidances to Help Facilitate the Development of Adjuvant Treatment for Kidney and Bladder Cancer

October 1, 2020

Media Inquiries

 Chanapa Tantibanchachai
 202-384-2219

The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research:

“Currently, there is significant variability in the design, conduct, and analysis of clinical trials for adjuvant (additional) treatment of both kidney cancer and bladder cancer. This variability negatively affects our ability to interpret trial results. Researchers need a consistent approach to eligibility criteria and imaging disease assessments to improve trials designed to facilitate development of therapies.

“The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in partnership with the National Cancer Institute and releasing draft guidances on clinical trial eligibility for these cancer types.

“Today, we are releasing draft guidances which, if finalized, would provide recommendations on development of adjuvant treatments in patients with renal cell carcinoma and bladder cancer. These draft guidances, if finalized, will assist researchers with recommendations on trial eligibility criteria, standardized imaging assessments, and determining disease recurrence that will improve interpretation of trial results for patients enrolled in clinical trials for these two cancer types."

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