Telix reported a 94.8% overall patient-level PPV (95% CI: 85.9%–98.2%) in its 140-patient Phase 3 registration study of TLX591-CDx (68Ga‑PSMA‑11) in Chinese men with biochemical recurrence of prostate cancer. Region-level PPV was 100% in the prostate bed and extra‑pelvic soft tissue/organ metastases, 94.7% in pelvic regions outside the prostate bed, and 87.0% in bone. High PPV extended to very low PSA strata, including 90.0%–93.3% for PSA 0.2–1.0 ng/mL and 100% at PSA 2.0–5.0+ ng/mL. Imaging prompted a change in management in 67.2% of patients.
The core developments are threefold. First, the China Phase 3 readout for Illuccix met the primary endpoint agreed with regulators, giving Telix and partner Grand Pharma the basis for a near-term NDA submission with the NMPA. Second, in the U.S., Telix is finalizing its NDA resubmission for TLX101‑CDx (18F‑floretyrosine) for glioma after a Type A meeting and is revising the statistical analysis plan alongside added clinical data. Third, the FDA issued a CRL for TLX250‑CDx (89Zr‑girentuximab) focused on CMC; following a Type A meeting, Telix indicates alignment on remediation and will meet FDA again in January to review its data plan for manufacturing comparability between the ZIRCON Phase 3 product and the commercial-scale process.
Strategically, the China Illuccix push is an expansion play anchored in executional feasibility. PPV at low PSA levels reinforces the clinical utility that has driven adoption in other markets, while China’s rapid buildout of PET/CT capacity creates a window for kit-based 68Ga deployment without reliance on cyclotrons. Partnering with Grand Pharma mitigates local market access and distribution risk. In the U.S., Telix’s dual resubmissions are defensive and corrective: clearing CMC hurdles for an antibody PET agent with complex logistics and tightening the evidentiary package for an 18F amino acid tracer where endpoint selection and analysis can be contentious. The outcome will shape the company’s credibility with regulators across its diagnostics portfolio.
For sites and sponsors, a China approval would accelerate PSMA-PET standardization in BCR pathways, increase scheduling volume, and necessitate operational readiness for generator-based 68Ga labeling and QC. CROs and imaging core labs should anticipate rising demand for PSMA- and amino acid PET read expertise, alongside tighter data integrity requirements as regulators scrutinize imaging-driven endpoints. U.S. neuro-oncology centers participating in expanded access for TLX101‑CDx will look for clarity on the revised SAP to ensure continuity between real-world use and any post-marketing evidence generation. Renal cancer centers eyeing TLX250‑CDx should plan around long imaging windows and radioisotope handling, but the gating factor remains CMC comparability; additional bridging data could influence site start-up timelines and pharmacy SOPs.
Near term, watch for the Illuccix China NDA filing and NMPA acceptance, including any signals on review class and site-of-care labeling constraints that could affect regional rollout. In the U.S., the key read is whether the FDA deems Telix’s TLX101‑CDx resubmission complete and whether review proceeds without new prospective efficacy data. For TLX250‑CDx, the January meeting and subsequent minutes will indicate if the agency is satisfied with the comparability plan or will require further validation runs or clinical re-bridging. Across all three programs, supply chain execution for radiolabeling, manufacturing scale-up, and harmonized reader training will be as determinative as the data. Competitive pressure from 18F PSMA agents and local Chinese alternatives could compress pricing and narrow switching windows, putting a premium on speed, reliability, and integration into guideline-driven care pathways.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
