FDA Expands Pluvicto Use for Prostate Cancer Treatment

The FDA has expanded the approval of Novartis's Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously undergone androgen receptor pathway inhibitor (ARPI) therapy and are suitable for delaying taxane-based chemotherapy. This expansion significantly increases the eligible patient pool and is based on the results of the Phase 3 PSMAfore trial, which demonstrated that Pluvicto reduced the risk of radiographic progression or death by 59% compared to a change in ARPI. The trial also showed improved median radiographic progression-free survival of 11.6 months versus 5.6 months for the control group, although the overall survival difference was not statistically significant. The recommended treatment regimen includes administering Pluvicto every six weeks for six doses. Side effects are consistent with the known safety profile, including radiation exposure and myelosuppression. Experts believe this approval could reshape treatment paradigms for patients with mCRPC who have not yet received chemotherapy.