FDA approves Pluvicto for PSMA+ mHSPC, advancing potential new standard of care across metastatic disease

CAR-T Digest - August 2020

31 July 2026: FDA approves Pluvicto for PSMA+ mHSPC, advancing potential new standard of care across metastatic disease

Novartis announced that the U.S. FDA has approved Pluvicto in combination with an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive prostate cancer, expanding its use across all stages of PSMA-positive metastatic prostate cancer and nearly doubling the eligible patient population
The approval is based on the phase 3 PSMAddition trial, where Pluvicto plus standard of care (ARPI + ADT) reduced the risk of progression or death by 28% at the primary analysis (HR=0.72) with a positive trend in overall survival (OS HR=0.80)
The approval addresses a significant unmet need in mHSPC, an incurable disease in which approximately half of patients progress to castration-resistant disease within 20 months despite current treatment options, supporting earlier treatment intensification
Pluvicto is a PSMA-targeted radioligand therapy that delivers lutetium-177 directly to PSMA-expressing tumor cells, enabling targeted radiation while limiting exposure to surrounding tissues. It can now be used from hormone-sensitive through castration-resistant metastatic prostate cancer
Strategically, the expanded FDA approval strengthens Novartis’ leadership in radioligand therapy, establishes Pluvicto as a treatment option across the metastatic prostate cancer continuum, and significantly expands its commercial opportunity while leveraging the company’s growing U.S. RLT manufacturing infrastructure