FDA Grants Breakthrough Therapy, Fast Track Status to 68Ga-NYM096 in ccRCC

The FDA has granted breakthrough therapy designation and fast track designation to 68Ga-NYM096, an investigational PET imaging agent targeting carbonic anhydrase IX (CAIX) for the detection of clear cell renal cell carcinoma (ccRCC).¹ The designations mark the first time a China-originated radiopharmaceutical has received FDA breakthrough therapy designation.

68Ga-NYM096 is being developed as a noninvasive PET imaging agent to characterize indeterminate renal masses identified on CT or MRI and to help differentiate ccRCC from non-ccRCC lesions. ccRCC is the most common subtype of renal cell carcinoma, accounting for approximately 75% of cases; the American Cancer Society estimates 80,450 new kidney cancer diagnoses and 15,160 kidney cancer deaths in the US in 2026.²

About 68Ga-NYM096

The breakthrough therapy designation was based on preliminary clinical data supporting the agent's potential to offer meaningful advantages over current diagnostic approaches for ccRCC.¹ Fast track designation is intended to facilitate development and expedite FDA review through more frequent sponsor-agency interactions, enhanced regulatory guidance during clinical development, and potential eligibility for rolling review of a new drug application.

The designations do not constitute marketing approval, and 68Ga-NYM096 remains investigational; its safety and efficacy have not been established.

The sponsor plans to initiate phase 1 trials of 68Ga-NYM096 in both China and the United States and said it will continue working with the FDA to advance the agent's clinical development. Additional clinical data on 68Ga-NYM096 are expected to be presented at the 2026 EANM Annual Congress.

"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,” said Peng Fang, founder and CEO, Norroy Bioscience, in a news release.

REFERENCES

1. NORROY BIOSCIENCE granted FDA breakthrough therapy and fast track designations for kidney cancer imaging product. News release. Norroy Bioscience Co., Ltd. August 19, 2026. Accessed August 20, 2026. https://www.biospace.com/press-releases/norroy-bioscience-granted-fda-breakthrough-therapy-and-fast-track-designations-for-kidney-cancer-imaging-product

2. Feng X, Zhang L, Tu W, Cang S. Frequency, incidence and survival outcomes of clear cell renal cell carcinoma in the United States from 1973 to 2014: A SEER-based analysis. Medicine (Baltimore). 2019 Aug;98(31):e16684. doi: 10.1097/MD.0000000000016684