October 1, 2020
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."
- Today, the U.S. Food and Drug Administration issued two draft guidances that, if finalized, will provide recommendations to sponsors seeking to develop drugs and biologics for adjuvant treatment of renal cell carcinoma and bladder cancer.
- “Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment,” provides draft guidance to sponsors regarding the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.
- “Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment,” provides draft guidance to sponsors developing drugs and biologics for the adjuvant treatment of muscle-invasive bladder cancer.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.