FDA grants breakthrough therapy, fast track designations to kidney cancer imaging agent

The FDA has granted Breakthrough Therapy and Fast Track designations to ⁶⁸Ga-NYM096, an investigational carbonic anhydrase IX (CAIX)-targeted radiopharmaceutical imaging agent for PET imaging of clear cell renal cell carcinoma (ccRCC).¹

⁶⁸Ga-NYM096 is being developed as a noninvasive PET imaging agent to help distinguish ccRCC from non-ccRCC lesions and characterize indeterminate renal masses identified on CT or MRI.

Breakthrough Therapy designation is granted to novel agents that have the potential to provide meaningful clinical advantages over current diagnostic approaches and address an unmet medical need. With Fast Track designation, the development process for ⁶⁸Ga-NYM096 can benefit from more frequent engagement with the FDA and eligibility for accelerated approval and priority review.

Developer Norroy Bioscience said the designations were based on preliminary clinical data evaluating the investigational radiopharmaceutical in patients with ccRCC.

"We have seen promising clinical data from the ongoing development of ⁶⁸Ga-NYM096, supporting its potential to advance the diagnosis and management of patients with ccRCC,” said Peng Fang, NORROY Founder and CEO, in a news release from the company.¹ “Additional clinical data of ⁶⁸Ga-NYM096 will be presented at the 2026 EANM Annual Congress. We plan to initiate Phase I clinical trials evaluating ⁶⁸Ga-NYM096 in both China and the United States and will continue to work closely with the FDA to advance its clinical development. We believe this innovative imaging agent has the potential to reshape the diagnosis and management of ccRCC and ultimately benefit more patients worldwide."

Preliminary data suggest diagnostic efficacy

The FDA designations follow preliminary clinical data presented by investigators at the 2026 American Society of Clinical Oncology Annual Meeting. In an open-label, multicenter study, 24 patients with primary or metastatic ccRCC underwent ⁶⁸Ga-NYM096 PET/CT. Of these, 23 patients had primary renal masses and 1 had suspected/confirmed metastatic disease. Some patients also underwent ¹⁸F-FDG PET/CT within 1 week before or after [⁶⁸Ga]Ga-NYM096 PET/CT to compare diagnostic efficacy between the 2 agents. The mean age of participants was 56.7 years (SD, 14.4).

Across the study population, the reported patient-level sensitivity, specificity, and accuracy of ⁶⁸Ga-NYM096 PET/CT were 100%, 90%, and 95.7%, respectively. For the subgroup with primary renal masses, corresponding values were 100%, 90%, and 95.5%, respectively.

The investigators also reported substantially greater uptake with ⁶⁸Ga-NYM096 than with ¹⁸F -FDG PET in patients who underwent both scans, with mean maximum standardized uptake values of 52.2 (SD, 34.1) and 5.5 (SD, 2.9), respectively (P < .001). The tumor-to-kidney ratio was also higher at 3.3 (SD, 3.0) vs 1.7 (SD, 3.0) (P < .05).

Based on these findings, the authors concluded, “[⁶⁸Ga-NYM096 PET/CT] has the potential to become a diagnostic product for both primary and metastatic ccRCC.”

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