Novartis’ Pluvicto has been approved by the US FDA in combination with an androgen receptor pathway inhibitor (ARPI) for patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Approval is based on the phase 3 PSMAddition trial, which showed Pluvicto reduced the risk of progression or death by 28% when combined with standard of care (SoC) compared to SoC alone. At a subsequent updated analysis, the Pluvicto combination further reduced the risk of progression or death by 33% with a positive overall survival (OS) trend favouring Pluvicto plus SoC, as data continues to mature ahead of final OS analysis.
Pluvicto can now be used across all stages of prostate-specific membrane antigen (PSMA)-positive metastatic prostate cancer, nearly doubling the eligible patient population. The approval builds on its established use in metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer, also known as metastatic castration-resistant prostate cancer (mCRPC).
“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.”
More than 186,000 men are diagnosed each year with mHSPC globally. Despite significant treatment advancements, about a third of patients do not achieve undetectable PSA with ARPI-ADT doublet therapy alone and half will progress to castration-resistant disease within 20 months, highlighting the need for earlier treatment intensification in this disease state. The PSMA biomarker is present in more than 80% of patients with prostate cancer.
“The treatment landscape for mHSPC is evolving, and this approval reflects a growing recognition that earlier treatment intensification matters,” said Michael Morris, 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.”