Full Press Release Details
Melbourne (Australia) | 13 May 2025
Telix today announces that that the pivotal Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68 Ga-PSMA-11) for prostate cancer imaging in Chinese patients has completed patient enrolment.
The Phase 3 Illuccix China study [1] is a prospective, open-label, single-arm, multicenter study conducted in collaboration with Telix’s strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The study, which enrolled 140 patients, aims to demonstrate equivalence of TLX591-CDx in imaging prostate cancer in Chinese and Western patients, in order to bridge to the marketing authorization granted to Illuccix by the United States (U.S.) Food and Drug Administration (FDA). The data will be used to file a marketing authorization application for TLX591-CDx with the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).
Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, “We are pleased to have completed this study in collaboration with Grand Pharma, which brings advanced PSMA-PET imaging one step closer for men living with prostate cancer in China. We extend our gratitude to the principal investigators, their clinical research teams, and the patients who participated in this important Phase 3 study.”
About Prostate Cancer in China
The Asia Pacific region comprises approximately one third of the world’s male population and includes many nations whose populations are ageing or increasingly adopting a more affluent, “Western-style” lifestyle, the two main demographic trends driving increasing cancer incidence rates. Consequently, the incidence of prostate cancer is increasing in many parts of the region.
In China, more than 134,000 men were diagnosed with prostate cancer in 2022 [2] , increasing by approximately 6% each year [3] . In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is estimated to have reached 1,240 by the end of 2023, compared with 133 in 2010 [4] .
TLX591-CDx (Illuccix) has not received a marketing authorization in China and is for investigational use only.
[1] ClinicalTrials.gov ID: NCT05847348
[2] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.
[3] Ye Dingwei et al. Lancet Oncology, 2022.
[4] Goetz Partners research 2020.