ccRCC PET Imaging Agent Earns FDA Breakthrough Therapy, Fast Track Statuses

The FDA has granted breakthrough therapy and fast track designations to [⁶⁸Ga] Ga-NYM096, an investigational PET imaging agent that targets carbonic anhydrase IX (CAIX) for imaging clear cell renal cell carcinoma (ccRCC), according to a news release from the developer, Norroy Bioscience.¹ [⁶⁸Ga] Ga-NYM096 is the first China-originated radiopharmaceutical to receive FDA breakthrough therapy designation and is being developed as a non-invasive tool to characterize indeterminate renal masses on CT or MRI and differentiate ccRCC from non-ccRCC lesions.

What preliminary clinical data support 68Ga-NYM096 in ccRCC?

Preliminary clinical data supporting the designations were presented in a poster session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and came from an open-label, single-center study of [⁶⁸Ga] Ga-NYM096 PET/CT in patients with an indeterminate renal mass or suspected metastatic ccRCC.² Investigators enrolled 24 patients with a mean age of 56.7 years (SD, 14.4). A total of 23 patients had an indeterminate primary renal mass scheduled for surgery, and 1 had an ex-renal lesion suspected of ccRCC scheduled for biopsy.

Patient-level sensitivity, specificity, and accuracy were 93.3%, 100%, and 95.8% for the full cohort, and 92.9%, 100%, and 95.7% for those with an indeterminate primary renal mass; among 23 evaluable primary lesions, positive and negative predictive values were 100% and 90%, respectively, and the patient with an ex-renal lesion was confirmed as a true positive by histopathology.

The maximum standardized uptake value (SUVmax) of the most active lesion in PET-positive patients with an indeterminate primary renal mass averaged 53.8 ± 32.3 (range, 4.9-111.8), significantly higher than the mean SUVmax of 6.1 ± 2.9 with 18F-FDG PET in the same patients (P <.001), and tumor-to-kidney ratio was similarly higher with [⁶⁸Ga] Ga-NYM096; 4.9 ± 3.9 vs 0.6 ± 0.3, respectively (P <.001).

What is 68Ga-NYM096 and how does it work?

[⁶⁸Ga] Ga-NYM096 is a gallium-68–labeled small molecule that targets CAIX, a tumor antigen highly expressed in ccRCC. [⁶⁸Ga] Ga-NYM096 showed a dissociation constant (KD) of 0.16 nM for the CAIX protein, reflecting higher affinity than a prior-generation compound, NY104, with a KD of 5.75 nM. The agent is given as an intravenous injection followed by a total-body PET/CT scan approximately 60 minutes later.

What is the regulatory significance of these designations?

Breakthrough therapy designation is intended for investigational products that may offer substantial improvement over available approaches for a serious condition, supported by preliminary clinical evidence. The developers stated that [⁶⁸Ga] Ga-NYM096 is the first China-originated innovative radiopharmaceutical to receive this designation.

Fast track designation is designed to facilitate development and expedite FDA review through more frequent agency interactions, enhanced regulatory guidance, and potential eligibility for rolling review of a new drug application. To date, the safety and efficacy of [⁶⁸Ga] Ga-NYM096 have not been fully established.

What’s next for 68Ga-NYM096’s clinical development?

"We have seen promising clinical data from the ongoing development of [⁶⁸Ga] Ga-NYM096, supporting its potential to advance the diagnosis and management of patients with ccRCC," stated Peng Fang, founder and chief executive officer of Norroy, in the press release.¹ "We plan to initiate phase 1 clinical trials evaluating [⁶⁸Ga] Ga-NYM096 in both China and the [US], and will continue to work closely with the FDA to advance its clinical development."

Additional clinical data are expected to be presented at the 2026 European Association of Nuclear Medicine (EANM) Annual Congress.

ccRCC accounts for approximately 70% to 80% of RCC cases, and an estimated 80,450 new cases of kidney cancer will be diagnosed in the US in 2026, with 15,160 deaths expected, according to the American Cancer Society.

The poster investigators noted that their findings were limited by a small sample size, including only 1 patient with metastatic disease, and a single-center design. They stated that results need confirmation in larger, multicenter cohorts.

References

1. Norroy Bioscience granted FDA Breakthrough Therapy and Fast Track designations for kidney cancer imaging product. News release. Norroy Bioscience. August 19, 2026. Accessed August 19, 2026. https://tinyurl.com/585ext6w
2. Xue Y, Yu W, Wu T, et al. [68Ga]Ga-NYM096 PET/CT in patients with indeterminate renal mass and suspected metastatic clear cell renal cell carcinoma: a preliminary study. J Clin Oncol. 2026;44(suppl 16):4537. doi:10.1200/JCO.2026.44.16_suppl.4537