ODAC backs usefulness of imaging agents for clear cell RCC

FDA's Oncologic Drugs Advisory Committee (ODAC) voted 16-0, with one abstention, that an imaging test would provide useful clinical information if it identified only clear cell renal cell carcinoma (RCC) -- but not other types of cancer in the kidney -- in patients with an indeterminate renal mass. FDA said a positive vote would mean such a test could use a Phase III primary endpoint evaluating performance characteristics, including sensitivity and specificity, rather than a primary endpoint evaluating clinical outcomes.

The standard of care for localized RCC is surgery. During discussion, panel members said that while a multitude of factors contribute to a diagnosis of clear cell RCC, being able to determine whether or not a tumor mass is clear cell RCC would be useful prior to deciding whether a patient should undergo surgery. Clear cell RCC is one of the more aggressive subtypes of RCC. ...