FDA approves Pluvicto for hormone-sensitive prostate cancer
Novartis has secured US Food and Drug Administration approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in metastatic hormone-sensitive prostate cancer (mHSPC), extending the radioligand therapy's label beyond its original indication in castration-resistant disease. The approval, announced on 31 July 2026, is based on the Phase III PSMAddition trial and positions Pluvicto as the only PSMA-targeted agent approved across all stages of metastatic prostate cancer.
The PSMAddition data showed Pluvicto, combined with standard-of-care androgen deprivation therapy plus an androgen receptor pathway inhibitor, reduced the risk of disease progression or death by 28% at primary analysis (HR 0.72; 95% CI: 0.58–0.90). An updated analysis, presented alongside the approval, improved that figure to a 33% risk reduction (HR 0.67; 95% CI: 0.55–0.82), with an overall survival trend favouring the Pluvicto arm (HR 0.80; 95% CI: 0.63–1.01). Overall survival data have not yet matured to a final analysis.
Safety and patient reach
The tolerability profile seen in PSMAddition was broadly consistent with Pluvicto's known profile from the earlier VISION and PSMAfore trials. Grade 3 or higher adverse events were reported in 50.7% of patients in the Pluvicto arm, compared with 43.0% in the standard-of-care arm. The most frequently reported all-grade events included dry mouth, fatigue, nausea, hot flush and anaemia. Health-related quality of life, assessed longitudinally, was described as maintained across both arms.
Michael Morris, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center and a principal investigator of PSMAddition, said the approval "meaningfully expands the options for physicians and represents real progress for patients," noting the recognition that earlier treatment intensification matters in mHSPC.
The expanded label is commercially significant. Novartis estimates the approval nearly doubles the number of patients eligible for Pluvicto in the United States. Globally, more than 186,000 men are diagnosed annually with mHSPC across the eight markets covered by the company's epidemiological data. With the PSMA biomarker expressed in more than 80% of prostate cancers, the addressable population is substantial, though real-world uptake will depend on PSMA-PET imaging access and reimbursement decisions.
Market context and competitive landscape
Pluvicto's expanded approval arrives into a crowded mHSPC treatment environment. The ARPI class already includes several approved agents in this setting, and the standard doublet of ADT plus an ARPI is well established. Novartis is now positioning RLT as an additional layer of treatment intensification rather than a replacement. The competitive dynamic here differs from mCRPC, where Pluvicto has faced fewer direct challengers at the mechanism level.
Broader radioligand therapy competition is accelerating. Several companies, including Eli Lilly following its acquisition of Point Biopharma, and Bristol Myers Squibb through its Rayze deal, are investing in RLT pipelines. Novartis is seeking to consolidate its first-mover position through manufacturing scale: the company now has five US RLT manufacturing sites either operational or under construction, with a stated delivery window of five days to treatment centres.
The next clinical milestone for the Pluvicto programme is the final overall survival readout from PSMAddition, which will be pivotal in shaping prescribing confidence in the earlier mHSPC setting. Novartis is also investigating Pluvicto in oligometastatic prostate cancer via the PSMA-DC study, which could further widen the eligible population if data are supportive.