US regulators announced Friday that Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) has been approved for patients with PSMA-positive, metastatic hormone-sensitive prostate cancer (mHSPC), significantly expanding the number of patients eligible for the radioligand therapy.
The approval extends Pluvicto's use beyond metastatic castration-resistant prostate cancer. "The treatment landscape for mHSPC is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters," said Michael Morris, a principal investigator of the pivotal PSMAddition study in the US.
In the trial, Pluvicto combined with standard of care – an androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) – reduced the risk of disease progression or death by 28% versus standard therapy alone at the primary analysis. Updated findings showed the benefit widening to a 33% reduction, according to Novartis, with overall survival (OS) trending in Pluvicto's favour with a 0.80 hazard ratio, though data remain immature.
Safety results were consistent with those from the VISION and PSMAfore studies, which supported Pluvicto's approvals in 2022 and 2025 in castration-resistant prostate cancer. At primary analysis, grade ≥3 adverse events (AEs) were reported in 50.7% of patients who received Pluvicto plus standard care compared to 43% for standard care alone.
Doubling eligible patient pool
The company estimates more than 186,000 men are diagnosed globally with mHSPC each year, and roughly half progress to castration-resistant disease within 20 months despite ARPI-ADT doublet therapy.
Novartis US president Victor Bultó said the expanded label "nearly [doubles] the number of patients who may benefit from this targeted approach."
Still, despite the strength of the radiographic progression-free survival (rPFS) signal, key opinion leaders (KOLs) who spoke to FirstWord expressed caution about broad first-line adoption, citing concerns over long-term marrow toxicity, uncertainty around OS durability in a crossover-heavy trial, and high incremental cost .
The approval comes as Novartis continues to expand its radioligand manufacturing network, with five US production sites operational or under construction to support anticipated demand.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.