ITM Isotope Technologies Munich SE (ITM) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ITM-94 ([68Ga]Ga-DPI-4452) as a diagnostic agent for the detection of clear cell renal cell carcinoma (ccRCC).
The designation was granted based on the potential of ITM-94 as a more effective, non-invasive diagnostic agent designed to improve outcomes for people living with ccRCC, a condition with high 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 Celine Wilke, chief medical officer of ITM.
“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 disease landscape, with potential utility in supporting clinical decision-making for indeterminate renal masses as well. This news highlights the innovation within our pipeline and the important role an effective diagnostic can play in cancer treatment.”
ITM-94 is a gallium-68-radiolabeled PET imaging agent and, together with radiotherapeutic compound ITM-91 ([177Lu]Lu-DPI-4452), comprise a first-in-class, peptide-based theranostic pair. The theranostic pair targets carbonic anhydrase IX (CAIX), a cell surface protein that plays a key role in the tumour microenvironment, promoting tumour growth, survival, invasion and metastasis.
ITM-94 is currently being evaluated in part D of the ongoing phase 1/2 clinical trial for its effectiveness to accurately detect ccRCC in patients with indeterminate renal masses (IDRM) when compared to CT/MRI imaging, with histopathological confirmation of diagnosis. Secondary endpoints include assessments of the imaging agent’s sensitivity, specificity and positive predictive value (PPV) and negative predictive value (NPV) compared to histology.
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