---
title: "FDA approves Novartis Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/294553335.md"
description: "The FDA has approved Novartis' Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer. This approval, based on Phase III PSMAddition trial results showing a 33% lower risk of progression or death, expands the drug's label to nearly double the eligible patient pool."
datetime: "2026-07-31T20:35:48.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/294553335.md)
  - [en](https://longbridge.com/en/news/294553335.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/294553335.md)
generator: "portal-rs"
---

# FDA approves Novartis Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer

-   Novartis won FDA clearance for Pluvicto with an ARPI in PSMA-positive metastatic hormone-sensitive prostate cancer. \* Phase III PSMAddition showed a 33% lower risk of progression or death at updated analysis; overall survival trended better (HR 0.80). \* Label expansion extends use across PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient pool. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Novartis AG published the original content used to generate this news brief on July 31, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**