Therapeutic Radiopharmaceuticals for Prostate Cancer
Summary
Lutetium Lu 177 vipivotide tetraxetan (Lu-177-PSMA-617) may be considered medically necessary for adults with PSMA-positive metastatic castration-resistant prostate cancer who have 1 or more PSMA-positive lesions, or metastatic disease that is predominately PSMA-positive with no dominant PSMA-negative metastatic lesions, and who have been treated previously with androgen receptor-directed therapy and taxane-based chemotherapy. It is considered investigational for prostate cancer when these criteria are not met. In March 2025, the FDA indication for Lu-177-PSMA-617 was updated to also include individuals with PSMA-positive mCRPC who have been treated with AR pathway inhibition and are considered appropriate to delay taxane-based chemotherapy.
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