The U.S. Food and Drug Administration (FDA) on Friday approved Novartis AG's Novartis (NVS) Pluvicto for use alongside an androgen receptor pathway inhibitor in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

This is a big deal because it moves Pluvicto into an earlier stage of the disease. Previously, the treatment was only approved for metastatic castration-resistant prostate cancer, a later and harder-to-treat stage. Now, with this expanded indication, the number of patients who could benefit from the therapy has nearly doubled.

FDA Expands Pluvicto To Earlier Prostate Cancer Setting

The approval is based on the Phase 3 PSMAddition study. Initial results showed that adding Pluvicto to the standard of care cut the risk of disease progression or death by 28% compared to standard treatment alone. A later analysis found an even bigger risk reduction of 33%, along with a favorable trend in overall survival.

That's the kind of data that makes regulators sit up and take notice. And for patients, it could mean a new standard of care across the metastatic disease spectrum.

Treatment Addresses Earlier Disease Stage

Globally, more than 186,000 men are diagnosed with mHSPC every year. While treatments have improved, about a third of these patients don't achieve undetectable PSA levels with standard therapies, and half progress to castration-resistant stages within 20 months. So there's a clear unmet need.

The safety profile of Pluvicto in this setting is consistent with what was seen in earlier trials, which should reassure doctors and patients alike. To make sure supply keeps up with demand, Novartis has five U.S. manufacturing facilities, which allows delivery to domestic treatment centers within five days.

Earlier FDA Expansion And Commercial Performance

This isn't the first time the FDA has expanded Pluvicto's reach. Back in March 2025, the agency approved it for prostate cancer patients with an expanded indication that roughly tripled the number of eligible patients, based on the Phase 3 PSMAfore trial. Those patients have prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer and have already been treated with an androgen receptor pathway inhibitor.

The commercial momentum is building too. In the second quarter, Pluvicto revenues jumped 43% to $651 million. That's a solid performance for a drug that's becoming a cornerstone of Novartis' oncology portfolio.

And Novartis isn't stopping there. In July, the FDA granted traditional approval for its oral medication Fabhalta (iptacopan). That drug is authorized to slow the decline of kidney function in adult patients with primary immunoglobulin A nephropathy who are at 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 market data.