FDA Fast Tracks ITM-94 For Clear Cell Renal Cell Carcinoma Diagnosis

The U.S. Food and Drug Administration (FDA) has granted fast track designation to ITM-94 ([68Ga]Ga-DPI-4452) to potentially serve as a diagnostic agent for the detection of clear cell renal cell carcinoma, which is the most common type of kidney cancer.

The development was announced in a news release issued by ITM Isotope Technologies Munich SE (ITM), the radiopharmaceutical biotech company behind ITM-94. According to the news release, the fast track designation was awarded based on the potential of ITM-94 to function as a more effective, non-invasive diagnostic agent.

“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,” Dr. Celine Wilke, chief medical officer of ITM, said in a statement included in the news release. “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.”

As described in the news release, ITM-94 is a gallium-68-radiolabeled PET imaging agent. Together with the radiotherapeutic compound ITM-91 ([177Lu]Lu-DPI-4452), it forms a first-in-class, peptide-based theranostic pair that targets carbonic anhydrase IX (CAIX), a cell surface protein that plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion, and metastasis.

ITM-94, the news release stated, is currently being evaluated in Part D of an ongoing phase 1/2 clinical trial for its effectiveness in accurately detecting ccRCC in patients with indeterminate renal masses when compared to CT or MRI imaging, with histopathological confirmation of diagnosis.

According to the FDA’s website, the fast track process is specifically intended to support and accelerate the development of drugs that address serious or life-threatening conditions, while also speeding up the review process to bring therapies to patients more quickly when there is an identified unmet medical need.

More Information About Clear Cell Renal Cell Carcinoma: What to Know

In adults in the United States, clear cell renal cell carcinoma is the most common type of kidney cancer, accounting for approximately 80% of all renal cell carcinoma cases. It is more common in adults than in children, comprising roughly 2% to 6% of kidney cancer cases among children and young adults, according to the National Cancer Institute.

Symptoms of clear cell renal cell carcinoma can vary. Some patients may experience pain or fatigue, while others may have no noticeable symptoms. Potential symptoms can include blood in the urine, pain, weight loss, fatigue, fever, or a lump on the side. Tumors may also be detected incidentally in patients who undergo imaging tests for unrelated reasons.

Currently, if clear cell renal cell carcinoma is suspected, a physician will typically order imaging tests such as X-rays, CT scans, or MRI to evaluate tumor size and assess whether the cancer has spread. To confirm the diagnosis, a biopsy may be performed, during which a small tissue sample is taken from the tumor using a needle and examined by a pathologist, the National Cancer Institute states on its website.

This fast track designation for ITM-94 underscores the potential for a more precise, non-invasive diagnostic approach that could improve detection, staging, and clinical decision-making for patients with clear cell renal cell carcinoma, the news release from ITM Isotope Technologies Munich SE (ITM) concluded.

Reference

1. "ITM Receives U.S. FDA Fast Track Designation for ITM-94 as a Diagnostic Agent for Clear Cell Renal Cell Carcinoma," by ITM Isotope Technologies Munich SE (ITM). News release; Nov. 17, 2025.
2. "Fast Track," by the U.S. FDA. Aug. 13, 2024. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
3. "Clear Cell Renal Cell Carcinoma," by the National Cancer Institute. Mar. 17, 2020. https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-kidney-tumors/clear-cell-renal-cell-carcinoma

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