FDA clears Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer

Novartis has recently announced that the US Food and Drug Administration has approved Pluvicto in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naïve or sensitive prostate cancer, more commonly known as metastatic hormone-sensitive prostate cancer.

The approval rests on findings from the Phase III PSMAddition trial, which showed Pluvicto reducing the risk of progression or death by 28% when combined with standard of care, comprising an androgen receptor pathway inhibitor and androgen deprivation therapy, against standard of care alone. A subsequent updated analysis pushed that risk reduction to 33%, accompanied by a positive overall survival trend favouring the Pluvicto combination as data continue to mature ahead of the final overall survival analysis.

“The treatment landscape for mHSPC is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters,” said Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, and a Principal Investigator of the study in the US. “Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients.”

Pluvicto can now be deployed across every stage of PSMA-positive metastatic prostate cancer, nearly doubling the number of patients who may benefit. The latest decision builds on its existing approval in metastatic androgen pathway modulation-resistant prostate cancer, also referred to as metastatic castration-resistant prostate cancer.

More than 186,000 men receive a metastatic hormone-sensitive prostate cancer diagnosis globally each year. Despite meaningful treatment advances, around a third of patients fail to reach undetectable PSA levels on androgen receptor pathway inhibitor and androgen deprivation therapy doublet treatment alone, and half will progress to castration-resistant disease within 20 months, highlighting the pressing need to intensify treatment at an earlier point. The PSMA biomarker is detectable in more than 80% of prostate cancer patients.

“This approval signals a new era in the treatment of prostate cancer, representing a shift toward more targeted, early intervention,” said Gina Carithers, CEO and President of the Prostate Cancer Foundation. “This milestone redefines prostate cancer care, ensuring that from day one of their metastatic diagnosis, men have a precision option.”

The safety and tolerability profile of Pluvicto remained consistent with what has been established in the PSMAfore and VISION studies. At the primary analysis, grade 3 or higher adverse events were recorded in 50.7% of those receiving Pluvicto plus standard of care, compared to 43.0% among those on standard of care alone. The most frequently reported adverse events of any grade included dry mouth, fatigue, nausea, hot flush, and anaemia. Health-related quality of life was preserved based on longitudinal assessment capturing patient experience over time, with comparable outcomes across both treatment arms in PSMAddition.

“Pluvicto is now approved across PSMA-positive metastatic prostate cancer, nearly doubling the number of patients who may benefit from this targeted approach,” said Victor Bultó, President, US, Novartis. “Patients with metastatic prostate cancer continue to face significant unmet need, underscoring the importance of introducing precision options earlier in the treatment journey. Backed by nearly a decade of leadership in radioligand therapy and continued investment in science and infrastructure, we are expanding this field and bringing its promise to more patients.”

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Related Topics and Keywords

FDA, metastatic disease, pluvicto, prostate cancer