Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) has advanced into earlier stages of metastatic prostate cancer, moving beyond its original post-chemotherapy mCRPC indication.
In March 2025, the FDA expanded Pluvicto's approval to PSMA-positive metastatic castration‑resistant prostate cancer (mCRPC) patients who have received one androgen receptor pathway inhibitor (ARPI) and are eligible to delay chemotherapy, roughly tripling the eligible patient pool.
Later, based on the PSMAddition Phase III trial, the FDA approved Pluvicto in combination with an ARPI plus androgen deprivation therapy (ADT) for PSMA‑positive metastatic hormone‑sensitive prostate cancer (mHSPC), extending use to earlier‑stage, hormone‑sensitive disease.
PSMAfore and PSMAddition trials showed that Pluvicto more than doubled median radiographic progression‑free survival in mCRPC and reduced the risk of progression or death by about 28–33% in mHSPC, with a favorable trend in overall survival.
Real‑world data and ongoing trials (e.g., PSMAddition, PSMA‑DC) reinforce that Pluvicto’s benefit is greatest when initiated earlier in the disease course, after one ARPI and before chemotherapy, supporting its use across multiple stages of PSMA‑positive metastatic prostate cancer.
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