Emerging CAIX PET Agent Garners FDA Breakthrough Therapy and Fast Track Designations for ccRCC

The Food and Drug Administration (FDA) has issued Breakthrough Therapy and Fast Track designations for the radiopharmaceutical ⁶⁸Ga-NYM096 in PET imaging of clear cell renal cell carcinoma (ccRCC), which reportedly comprises 70 to 80 percent of cases of renal cell carcinoma (RCC).¹

Targeting carbonic anhydrase IX (CAIX), 68Ga-NYM096, enables differentiation of ccRCC from indeterminate renal masses originally detected with computed tomography (CT) or MRI exams, according to Norroy Bioscience, the developer of ⁶⁸Ga-NYM096.

Preliminary research involving ⁶⁸Ga-NYM096 in patients with metastatic ccRCC revealed a significantly higher mean SUVmax in the most active lesions of 115 in comparison to 11.1 for ¹⁸F-FDG as well as a significantly higher tumor-to-blood tumor ratio (102.6 vs. 6.6).²

In another study presented at the ASCO conference earlier this year, researchers found that ⁶⁸Ga-NYM096 offered patient-level sensitivity of 100 percent, specificity of 90 percent and accuracy of 95.7 percent for patients with primary ccRCC.³

“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. … We believe this innovative imaging agent has the potential to reshape the diagnosis and management of ccRCC and ultimately benefit more patients worldwide,” noted Peng Fang, the founder and CEO of Norroy Bioscience.

Norroy Bioscience is planning to commence phase I studies of ⁶⁸Ga-NYM096 in China and the United States and added that more clinical data on the PET agent will be presented at the upcoming European Association of Nuclear Medicine (EANM) Annual Congress in October.

References

1. Norroy Bioscience. Norroy Bioscience granted FDA breakthrough therapy and fast track designations for kidney cancer imaging product. PR Newswire. Available at: https://www.prnewswire.com/news-releases/norroy-bioscience-granted-fda-breakthrough-therapy-and-fast-track-designations-for-kidney-cancer-imaging-product-302854931.html . Published August 19, 2026. Accessed August 19, 2026.

2. Zhu W, Huo L, Yan X, Liu M. 68Ga-NYM096 PET/CT in patients with metastatic clear cell renal cell carcinoma: a preliminary study. J Nucl Med. June 2025, 66(supp1) 251244. Available at: https://jnm.snmjournals.org/content/66/supplement_1/251244 .

3. Xue Y, Yu W, Wu T, et al. 68Ga Ga-NYM096 PET/CT in patients with primary and metastatic clear cell renal cell carcinoma: a preliminary study. Presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting May 29-June 2, 2026, Chicago. Available at: https://ascopubs.org/doi/10.1200/JCO.2026.44.16_suppl.4537 .