Telix Pharmaceuticals Limited (ASX: TLX), a commercial-stage global radiopharmaceutical company advancing targeted theranostics to improve outcomes for people with cancer across the patient journey, has announced a significant regulatory milestone. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. The company successfully concluded a Type B meeting with the United States (U.S.) Food and Drug Administration (FDA), securing alignment to advance Part 2 of its ProstACT Global Phase 3 trial for its therapeutic candidate, TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), in metastatic castration-resistant prostate cancer.
Following a review of the Part 1 safety and dosimetry data and the Part 2 protocol design, the FDA confirmed that the safety data from Part 1 is sufficient to enable progression of Part 2 of ProstACT Global into the U.S. In Part 2, TLX591-Tx will be administered in two doses, 14 days apart, in combination with one of three randomised standard-of-care (SOC) therapies: abiraterone, enzalutamide, or docetaxel. Telix and the FDA also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan, establishing a consistent framework for study execution as enrolment continues internationally and expands into the U.S.
Dr. David N. Cade, Group Chief Medical Officer at Telix, commented, “This is an excellent outcome that enables submission of our IND amendment for initiation of Part 2 of ProstACT Global in the U.S. Part 2 continues to enrol strongly in regions where recruitment is open.” Initiation of Part 2 in the U.S. remains subject to the FDA’s review of an Investigational New Drug (IND) amendment. This IND amendment will also be aligned with a pending regulatory submission to initiate the ProstACT Global study in Europe. The trial continues to enrol patients in regions where Part 2 is already approved, including Australia, New Zealand, Canada, Türkiye, and the United Kingdom.
