USFDAJul 2, 2026, 04:33 PM
Telix Receives FDA Agreement for ProstACT Global Phase 3 Study
AI Summary
Telix Pharmaceuticals announced a successful Type B meeting with the U.S. FDA regarding its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer. The FDA agreed with the Part 2 protocol design and confirmed that Part 1 safety data is sufficient, enabling the study's expansion into the U.S. This alignment provides a consistent framework for the trial, which is already recruiting internationally, pending an Investigational New Drug (IND) amendment for U.S. initiation.
Key Highlights
- FDA agreed with the clinical protocol and statistical framework for ProstACT Global Phase 3 Part 2.
- Part 1 safety data for TLX591-Tx was deemed sufficient for U.S. progression.
- TLX591-Tx is administered in two doses, 14 days apart, in combination with standard of care therapies.
- The study targets approximately 490 patients with metastatic castration-resistant prostate cancer.
- Part 2 continues to recruit internationally and will expand into the U.S. pending IND amendment.
- TLX591-Tx is designed to minimize kidney toxicity, xerostomia, and dry eye.
Price Impact
More from TLX