Novartis Wins Expanded FDA Approval for Peptide-Based Prostate Cancer Therapy Pluvicto

Novartis has secured an expanded FDA approval for Pluvicto, a radioligand peptide therapy targeting PSMA-positive metastatic castration-resistant prostate cancer. The new indication allows Pluvicto to be used before chemotherapy, a significant shift from its original approval which limited it to patients who had already failed prior treatments.

The expansion was supported by data from the PSMAddition Phase III trial, which demonstrated a 28 percent reduction in the risk of disease progression or death compared to standard of care alone. This positions Pluvicto as one of the most successful peptide-based oncology therapies currently on the market and validates the broader concept of using peptide conjugates to deliver targeted radiotherapy.

The approval also reinforces the growing role of peptides beyond metabolic disease. While GLP-1 agonists dominate headlines, peptide-drug conjugates and radioligand therapies represent a parallel track of innovation where peptides serve as precision targeting vehicles rather than direct therapeutic agents.