The FDA has approved Novartis’ Pluvicto in combination with an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive prostate cancer, expanding its use across PSMA-positive metastatic prostate cancer and nearly doubling the eligible patient population. The approval is based on Phase III PSMAddition data showing Pluvicto reduced the risk of progression or death by 28% in the original analysis and by 33% in an updated analysis, with a positive overall survival trend still maturing.
The new indication moves Pluvicto earlier in the treatment journey for metastatic prostate cancer, a disease that remains incurable and often progresses quickly despite current therapy. Novartis said more than 186,000 men are diagnosed each year with mHSPC globally, and about half progress to castration-resistant disease within 20 months. The company said the PSMA biomarker is present in more than 80% of prostate cancer patients, supporting a precision approach earlier in disease.
Michael Morris of Memorial Sloan Kettering Cancer Center said the approval reflects growing recognition that earlier treatment intensification matters and gives physicians another option at this stage of disease. Gina Carithers of the Prostate Cancer Foundation said the milestone marks a shift toward targeted, early intervention and gives men a precision option from the time of metastatic diagnosis.
Novartis said the safety profile and tolerability of Pluvicto were consistent with prior studies, with the most common adverse events including dry mouth, fatigue, nausea, hot flush and anemia. Health-related quality of life was maintained in the study.
Victor Bultó, president of Novartis US, said the approval nearly doubles the number of patients who may benefit from the therapy and underscores the importance of introducing precision options earlier in metastatic disease. The company added that it has five US radioligand therapy manufacturing sites operational or under construction to help meet demand.
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