Wilex AG reported that the U.S. Food and Drug Administration's or FDA
Oncologic Drugs Advisory Committee or ODAC discussed the question: Would an
imaging test provide useful clinical information if it identified only
clear cell renal cell carcinoma or ccRCC within the kidney of patients with
an indeterminate renal mass? ODAC voted by 16 to 0 (1 abstention) in
support of the imaging information being clinically useful.
Wilex noted that after the vote the ODAC discussed to what extend the performance characteristics of the imaging test (sensitivity / specificity /
reproducibility) determined in patients undergoing resection of a kidney
mass providing histopathology as standard of truth could be used to
estimate how the imaging agent would perform among patients who may be
managed with 'active surveillance' rather than surgical resection.
Wilex said, based on the recommendation that, the company and FDA will discuss the further development strategy of its diagnostic candidate Redectane in a meeting which is planned for September 2012.
For comments and feedback: editorial@rttnews.com