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). 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.”