Novartis Pluvicto (lutetium (177Lu) vipivotide tetraxetan) receives MHRA authorisation for new indication for eligible patients with PSMA‑positive metastatic castration‑resistant prostate cancer

CAR-T Digest - August 2020

Weekly Digest - February 2026

16 February 2026: Novartis Pluvicto (lutetium (177Lu) vipivotide tetraxetan) receives MHRA authorisation for new indication for eligible patients with PSMA‑positive metastatic castration‑resistant prostate cancer

Novartis announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for Pluvicto (lutetium-177 vipivotide tetraxetan) for adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have progressed on or after androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy
This authorization enables eligible patients in the UK to receive Pluvicto earlier in the treatment pathway, addressing a significant unmet need for therapies that can delay disease progression and postpone chemotherapy while helping maintain quality of life
The approval is based on results from the Phase 3 PSMAfore trial, where Pluvicto demonstrated a statistically significant 59% reduction in the risk of radiographic progression or death compared with a change in ARPI therapy, extending median radiographic progression-free survival to 9.3 months versus 5.6 months
Although overall survival did not reach statistical significance in the primary analysis due to high crossover from the control arm, adjusted analyses suggested a meaningful survival benefit, and the therapy showed an acceptable safety profile with predominantly low-grade adverse events
With prostate cancer remaining the most commonly diagnosed cancer in the UK, this expanded indication reinforces Novartis’ commitment to advancing radioligand therapies and improving access to innovative treatment options for patients living with advanced disease