Also known as: ARPI
Telix gained FDA alignment to advance ProstACT Global Phase 3 into U.S. Part 2 for TLX591-Tx in mCRPC, with safety data from Part 1 deemed sufficient. The trial will combine the therapy with abiraterone, enzalutamide, or docetaxel, pending IND amendment review.
European guidelines now recommend lutetium-177 PSMA-617 for advanced prostate cancer, while a machine-learning model predicts treatment radiation dose. A study finds DOACs safe with modern prostate cancer drugs.
Novartis reported Phase III PSMAddition data showing Pluvicto plus standard of care cut the risk of PSA progression by 58% in PSMA-positive metastatic hormone-sensitive prostate cancer. Regulatory decisions in the United States, China and Japan are expected in the second half of 2026.
Telix said Part 1 of the ProstACT Global Phase 3 study met its primary objectives for TLX591-Tx in mCRPC. The company reported acceptable safety, no new safety signals and progression plans for Part 2.
PSMA-PET imaging leads to earlier use of advanced therapies like ARPIs in prostate cancer patients compared to bone scans. Real-world data on 177Lu-PSMA-617 shows comparable efficacy to the VISION trial in mCRPC patients.
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
Phase 3 PSMAddition showed that adding 177Lu-PSMA-617 to ADT plus an ARPI improved radiographic progression-free survival in PSMA-positive mHSPC. Health-related quality of life and pain were largely maintained.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Pluvicto (lutetium-177 vipivotide tetraxetan) received MHRA authorization for earlier use in metastatic castration-resistant prostate cancer, while pooled trial data demonstrates improved progression-free survival without increased toxicity.
Real-world analyses of Novartis' Pluvicto show a median PFS of 13.5 months in taxane-naive mCRPC patients, with better outcomes when used after one ARPI. Additional data indicate subsequent therapies remain effective after Pluvicto, while a separate analysis found gaps in guideline-adherent treatment for mHSPC.
