Telix Pharmaceuticals Granted July Pre-IND Meeting with US FDA for Phase III ProstACT Study
Melbourne (Australia)– 14th May 2020. Telix has been granted a Type B pre-IND meeting with the FDA in relation to the Company’s planned Phase III ProstACT trial for TLX591
Telix Pharmaceuticals Limited is pleased to announce that it has been granted a Type B pre-IND meeting with the United States Food and Drug Administration (FDA) in relation to the Company’s planned Phase III ProstACT trial for TLX591 (177Lu-DOTA-rosopatamab) for the treatment of metastatic castrate-resistant prostate cancer. The meeting date has been scheduled for the 7th July, 2020.
Telix’s planned Phase III ProstACT trial is a second-line study in men with metastatic castrate-resistant prostate cancer whose disease has progressed following initial treatment. The study will examine the effectiveness of TLX591 in combination with best standard care, compared with best standard care alone. The trial will recruit patients primarily in Australia and the United States, subject to regulatory approvals to conduct the study.
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