ITM secures U.S. FDA fast-track designation for kidney cancer PET agent

Radiopharmaceutical biotech firm Isotope Technologies Munich (ITM) has secured fast-track designation from the U.S. Food and Drug Administration (FDA) for its kidney cancer diagnostic/therapeutic agent.

ITM-94 is a gallium-68-radiolabeled PET imaging agent. Along with the radiotherapeutic compound ITM-91 (Lu-177 Lu-DPI-4452), the two make up a peptide-based theranostic pair, which targets carbonic anhydrase IX, a cell surface protein that plays a key role in the tumor microenvironment, the company said.

Both are being evaluated in a clinical trial that will assess their safety, tolerability, imaging characteristics, and efficacy in patients with unresectable, locally advanced, or metastatic solid tumors, according to ITM.