Novartis (NYSE: NVS) announced that the U.S. Food and Drug Administration has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use in combination with an androgen receptor pathway inhibitor in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).

The approval is based on results from the Phase III PSMAddition trial, in which Pluvicto combined with standard of care reduced the risk of disease progression or death by 28% compared to standard of care alone. A subsequent updated analysis showed a further reduction of 33%, with a positive overall survival trend favoring the Pluvicto combination, though final overall survival data have not yet matured.

The approval expands Pluvicto's indicated use beyond its previously established role in metastatic castration-resistant prostate cancer, allowing the drug to be used across all stages of PSMA-positive metastatic prostate cancer. Novartis stated this expansion nearly doubles the eligible patient population.

More than 186,000 men are diagnosed annually with mHSPC globally, according to the press release. The PSMA biomarker is present in more than 80% of prostate cancer patients.

Grade 3 or higher adverse events were reported in 50.7% of patients receiving Pluvicto plus standard of care, compared to 43.0% in the standard of care group. The most common adverse events across all grades included dry mouth, fatigue, nausea, hot flush, and anemia.

Michael Morris, MD, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center and a principal investigator of the U.S. study, said the approval "meaningfully expands the options for physicians and represents real progress for patients."