A candidate radio-diagnostic has received ‘fast track’ designation from the US Food and Drug Administration for its protential use in combination with a therapeutic to identify and treat clear cell renal cell carcinoma, the most common type of kidney cancer. ITM-94 is a radiolabeled gallium 68 imaging agent which is in a Phase 1/2 trial in patients with locally advanced or metastatic solid tumours. It is being developed with ITM-91, an investigational radioparmaceutical. The combination is known as a theranostic.
The multi-part trial is currently assessing whether to increase doses of the therapeutic agent in patients whose tumours show carbonic anhydrase IX (CAIX), a protein that is overexpressed in many solid tumours and particularly in clear cell renal cell carcinoma. This will be shown by uptake of the imaging tracer. Based on the results, a decision will be taken on the scope of the investigational product’s indication.
In a statement, Celine Wilke, ITM’s chief medical officer, said that data from the trial are promising and suggest that ITM-94 could change how clinicians diagnose and stage patients across the larger clear cell renal cell carcinoma landscape.
The FDA’s fast track designation is a regulatory incentive for new diagnostics and therapeutics which gives developers more access to the agency’s staff during clinical development. However the designation does not guarantee approval.
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