Telix Pharmaceuticals has secured alignment from the United States Food and Drug Administration (FDA) to advance the ProstACT Global Phase 3 trial into the U.S. following a successful Type B meeting. The FDA confirmed that safety data from Part 1 of the study is sufficient to enable progression into Part 2, which involves administering TLX591-Tx in two doses, 14 days apart, in combination with standard-of-care therapies. This agreement establishes a consistent framework for study execution as enrollment expands internationally and into the U.S.

The FDA and Telix achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan across three randomized standard-of-care combination cohorts: abiraterone, enzalutamide, or docetaxel. Part 2 continues to recruit in jurisdictions where the study has regulatory approval, including Australia, New Zealand, Canada, Türkiye, and the United Kingdom. Regulatory approval has also been received to commence the study in China, Singapore, and South Korea.

David N. Cade, MD, Group Chief Medical Officer at Telix, stated that the outcome enables the submission of an Investigational New Drug (IND) amendment for the initiation of Part 2 in the U.S. He noted that enrollment remains strong in regions where recruitment is open. The IND amendment will also be aligned with a pending regulatory submission to initiate the ProstACT Global study in Europe.

Neeraj Agarwal, MD, Professor of Medicine at Huntsman Cancer Institute and ProstACT Global Principal Investigator, highlighted the potential of TLX591-Tx to redefine radiopharmaceutical therapy integration. He emphasized that the complete treatment course is delivered over approximately two weeks, allowing physicians to layer it into existing regimens with minimal interruption. This flexibility may help preserve future treatment options for patients with metastatic prostate cancer.

ProstACT Global Trial Details

ProstACT Global is an international, multicenter trial divided into two parts. Part 1 was a safety and dosimetry lead-in with 36 patients, which is now complete. Part 2 is a 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients.

Eligible patients must have confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) assessed with a 68Ga-PSMA-11 PET imaging agent following prior treatment with one androgen receptor pathway inhibitor (ARPI). The antibody-based approach of TLX591-Tx demonstrates differentiated targeting and pharmacology compared to other PSMA-targeted small molecule radioligand therapies. Long-term follow-up has not observed significant acute or delayed kidney toxicity, as the agent is hepatically excreted. Additionally, TLX591-Tx shows minimal salivary and lacrimal gland uptake, reducing the prevalence of dry mouth and dry eye.

Telix Pharmaceuticals Limited announced it will host an educational webinar to discuss unmet needs in neurologic oncology, specifically glioma and glioblastoma, and how theranostics may address these challenges. The event aims to provide physician perspectives on future therapeutic directions within the company's Neuro-Oncology Portfolio.

David N. Cade, MD, Telix Group Chief Medical Officer, will deliver a clinical update. Following the presentation, a fireside chat will feature Nelleke Tolboom, MD, a Nuclear Medicine physician and academic faculty member at UMC Utrecht in the Netherlands, and Josef Pichler, MD, Head of the Neuro-oncological Center at Kepler University Hospital Linz in Austria.

The session will conclude with a question-and-answer segment involving Dr. Cade and Richard Valeix, CEO of Telix Therapeutics. Participants can register for the event through the provided link.

Webinar Details

Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals to address unmet medical need in oncology and rare diseases. The company is headquartered in Melbourne, Australia, with international operations across the United States, United Kingdom, Brazil, Canada, Europe, and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).