ITM Wins FDA Fast Track Status for Renal Cell Carcinoma Diagnostic Agent

ITM Isotope Technologies Munich SE has received U.S. FDA Fast Track designation for ITM-94, a gallium-68 PET imaging agent designed to detect clear cell renal cell carcinoma (ccRCC), the company announced on November 17. The designation recognizes ITM-94’s potential to offer a more effective, non-invasive diagnostic option for a cancer with a significant unmet medical need.

“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,” said Dr. Celine Wilke, ITM’s chief medical officer. She added that early clinical data “suggest ITM-94 could change how clinicians diagnose and stage patients across the broader ccRCC disease landscape,” including use in evaluating indeterminate renal masses.

ITM-94 pairs with the company’s therapeutic candidate ITM-91 to form a first-in-class peptide-based theranostic duo targeting carbonic anhydrase IX (CAIX), a tumor-associated cell surface protein involved in cancer growth and metastasis. While ITM-91 delivers targeted radiotherapy, ITM-94 enables PET imaging of CAIX-expressing tumors.

The diagnostic agent is currently being studied in Part D of an ongoing Phase 1/2 trial assessing its accuracy in identifying clear cell renal cell carcinoma in patients with indeterminate renal masses. Trial endpoints include comparisons with CT/MRI and histopathology, as well as sensitivity, specificity, and predictive value analyses.

Fast Track designation allows for closer interaction with the FDA during development and may provide eligibility for accelerated approval or priority review if criteria are met.