The FDA expanded Novartis’ Pluvicto radioligand therapy label to include PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), in combination with an androgen receptor pathway inhibitor. This new indication advances Pluvicto earlier in the disease setting and nearly doubles the eligible patient population compared with the prior mCRPC label. Regulators based the approval on data from the PSMAddition trial, where the combination lowered the risk of progression or death versus standard of care. Novartis also emphasized that Pluvicto can be deployed across stages of PSMA-positive metastatic prostate cancer. The move strengthens Pluvicto’s commercialization ramp ahead of peak-sales competition and increases patient access to a precision radiotherapy option earlier in the treatment journey.