The U.S. Food and Drug Administration (FDA) on Friday approved Novartis AG’s (NYSE:NVS) Pluvicto for its radioligand therapy to be used alongside an androgen receptor pathway inhibitor.
This combination is approved for metastatic hormone-sensitive prostate cancer (mHSPC) patients.
FDA Expands Pluvicto To Earlier Prostate Cancer Setting
Consequently, the eligible patient base for the therapy has nearly doubled.
Previously, the treatment was established for a later stage known as metastatic castration-resistant prostate cancer.
The approval stems from the Phase 3 PSMAddition study. Initial data revealed that combining Pluvicto with the standard of care slashed the risk of disease progression or death by 28% compared to standard treatments alone.
A later analysis demonstrated an even greater risk reduction of 33%, alongside a favorable trend in overall survival.
Treatment Addresses Earlier Disease Stage
Globally, over 186,000 men receive an mHSPC diagnosis annually. While treatments have improved, about a third of these individuals fail to achieve undetectable PSA levels with standard therapies, and half advance to castration-resistant stages within 20 months.
The safety profile of Pluvicto aligns with previous trials. To meet anticipated demand, the pharmaceutical giant boasts five U.S. manufacturing facilities, enabling delivery to domestic treatment centers within five days.
Earlier FDA Expansion And Commercial Performance
In March 2025, the FDA approved Pluvicto for prostate cancer patients, with an expanded indication that approximately triples the number of patients eligible to receive Pluvicto, based on the Phase 3 PSMAfore trial results.
The patients have prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer and have been treated with an androgen receptor pathway inhibitor therapy.
In the second quarter, radioligand therapy Pluvicto revenues climbed 43% to $651 million.
In July, the FDA granted traditional approval for Novartis’ oral medication, Fabhalta (iptacopan).
The treatment is authorized to slow the decline of kidney function in adult patients suffering from primary immunoglobulin A nephropathy who face a high risk of disease progression.
NVS Price Action: Novartis shares were down 1.74% at $153.43 at the time of publication on Monday, according to Benzinga Pro data.
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