ODAC to consider clinical usefulness of kidney cancer imaging tests

FDA released briefing documents ahead of Wednesday's Oncologic Drugs Advisory Committee meeting to discuss the potential clinical usefulness of imaging tests that identify only clear cell renal cell carcinoma (RCC) but not other types of cancer within the kidney -- such as Redectane from Wilex AG (Xetra:WL6). FDA said if such a test is deemed "clinically useful," a Phase III study may use a primary endpoint evaluating performance characteristics, including sensitivity and specificity. If clinical usefulness is uncertain, the endpoint will likely need to measure health benefits, according to the documents. The committee will vote whether such imaging tests would provide "useful clinical information."

The committee will discuss Redectane's development plan but will not review any specific clinical data or vote on Redectane's risk-benefit profile. FDA asked Wilex to participate in the meeting after suggesting last year that the company should conduct an outcomes study of the radiolabeled mAb against carbonic anhydrase IX (CAIX) prior to submitting a BLA (see BioCentury, June 27, 2011). ...