Emerging PET Agent Garners FDA Fast Track Designation for Clear Cell Renal Cell Carcinoma

The Food and Drug Administration (FDA) has granted a fast track designation for the positron emission tomography (PET) imaging agent ITM-94 in the detection of clear cell renal cell carcinoma (ccRCC).

The combination of the gallium-68 radiolabeled PET agent ITM-94 with the radiotherapeutic agent ITM-91 ((177Lu)Lu-DPI-4452) provides a peptide-based theranostic approach for imaging in patients with ccRCC, according to ITM Isotope Technologies, the developer of ITM-94. The company said the combination of ITM-94 and ITM-91 provide effective targeting of the cell surface protein carbonic anhydrase IX (CAIX), which can be a contributing factor in tumor growth, invasion and metastatic spread.

In addition to ITM-94 demonstrating favorable tolerability and a high tumor-to-background ratio for ccRCC in preliminary findings from an ongoing phase 1/2 trial, ITM Isotope Technologies noted that a subsequent part of the study will evaluate the effectiveness of ITM-94 in classifying indeterminate renal masses.

“The FDA’s fast track designation is a validation of ITM-94’s potential to aid in the non-invasive diagnosis of renal cell carcinoma,” noted Celine Wilke, M.D., the chief medical officer of ITM Isotope Technologies. “We have seen promising data in our ongoing clinical trial that suggest ITM-94 could change how clinicians diagnose and stage patients across the broader ccRCC (clear cell renal cell carcinoma) disease landscape, with potential utility in supporting clinical decision-making for indeterminate renal masses as well.”