USFDAJul 1, 2026, 09:32 PM
Telix Pharmaceuticals Aligns with FDA for ProstACT Global Phase 3 Study Part 2 in U.S.
AI Summary
Telix Pharmaceuticals announced successful alignment with the U.S. Food and Drug Administration (FDA) to advance Part 2 of its ProstACT Global Phase 3 trial into the U.S. The FDA confirmed that safety data from Part 1 of the study is sufficient, enabling progression for TLX591-Tx in metastatic castration resistant prostate cancer. This alignment covers the clinical protocol, statistical analysis plan, and ongoing safety monitoring for Part 2, which will combine TLX591-Tx with standard-of-care therapies. Initiation in the U.S. is pending FDA review of an Investigational New Drug (IND) amendment, while international recruitment for Part 2 continues.
Key Highlights
- FDA and Telix aligned on advancing ProstACT Global Phase 3 study Part 2 into the U.S.
- FDA confirmed Part 1 safety data sufficient for U.S. progression of TLX591-Tx trial.
- Part 2 involves TLX591-Tx administered in two doses, 14 days apart.
- Trial combines TLX591-Tx with abiraterone, enzalutamide, or docetaxel standard-of-care therapies.
- FDA and Telix aligned on Part 2 clinical protocol, statistical analysis, and safety monitoring plan.
- ProstACT Global (NCT06520345) targets approximately 490 patients in Part 2.
- Part 2 is actively recruiting in Australia, New Zealand, Canada, Türkiye, UK, China, Singapore, and South Korea.
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