FDA alignment to advance ProstACT Global phase 3 trial

CAR-T Digest - August 2020

Weekly Digest - July 2026

02 July 2026: FDA alignment to advance ProstACT Global phase 3 trial

Telix Pharmaceuticals has reached alignment with the U.S. FDA to advance the ProstACT Global phase 3 trial of TLX591-Tx, a PSMA-targeted radio antibody-drug conjugate, into Part 2 in the United States, marking an important regulatory milestone for the company’s lead prostate cancer therapeutic candidate
The FDA confirmed that Part 1 safety and dosimetry data were sufficient to support progression into the randomized Part 2 study and aligned with Telix on the clinical protocol, statistical analysis plan, and ongoing safety monitoring framework. Part 1 demonstrated an acceptable safety and tolerability profile across all three standard-of-care combination cohorts, with no new safety signals identified
ProstACT Global is evaluating TLX591-Tx in combination with standard-of-care therapies-abiraterone, enzalutamide, or docetaxel-for patients with PSMA-positive metastatic castration-resistant prostate cancer previously treated with one androgen receptor pathway inhibitor, aiming to integrate radiopharmaceutical therapy earlier in the treatment paradigm
TLX591-Tx is a PSMA-targeted Lutetium-177 radio antibody-drug conjugate designed to deliver targeted radiation directly to prostate cancer cells. The phase 3 study evaluates a two-dose regimen administered 14 days apart in combination with standard-of-care therapy, reflecting real-world clinical practice
Strategically, the FDA alignment paves the way for U.S. expansion of the global phase 3 program, supports upcoming IND and European regulatory submissions, and strengthens Telix’s position in the rapidly evolving radiopharmaceutical oncology landscape as it advances one of the most clinically advanced PSMA-targeted rADC programs toward potential commercialization