Telix progresses key clinical trials, regulatory filings for cancer therapies

Telix announced the completion of patient enrolment for Part 1 of its ProstACT Global Phase 3 study for TLX591 in mCRPC patients. The independent data monitoring committee has recommended proceeding to Part 2, with initial patients already dosed in approved jurisdictions. Telix also plans to file a clinical trial application with the EMA to expand into EU sites.

In its precision medicine portfolio update, Telix reported positive top-line results from the Illuccix China Phase 3 registration study, meeting its primary endpoint for prostate cancer imaging. This paves the way for a near-term NDA submission in China.

Furthermore, Telix provided updates on its FDA resubmissions: TLX101-CDx for glioma is progressing well with finalization underway following collaborative interactions. For TLX250-CDx for ccRCC, Telix believes it has aligned with the FDA on remediation of CMC deficiencies, with an additional meeting scheduled for January to review comparability data.