# FDA Expands Pluvicto Approval to Metastatic Hormone-Sensitive Prostate Cancer, Nearly Doubling Eligible Patients

> fda · REPORTED · 2026-07-31

On July 31, 2026, the FDA approved Novartis's Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for adults with PSMA-positive metastatic hormone-sensitive prostate cancer, expanding its use beyond castration-resistant disease. The PSMAddition trial showed a 33% reduction in risk of progression or death compared to standard of care alone, and Novartis estimates the expanded label nearly doubles the eligible patient population.

About Novartis (Pluvicto): Pluvicto is Novartis's targeted radioligand therapy that attaches to the PSMA protein on prostate cancer cells and delivers radiation directly to kill them, serving men with advanced metastatic prostate cancer.

- Company: Novartis (Pluvicto)
- Sector: oncology
- Primary source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.