The FDA expanded Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) into metastatic hormone-sensitive prostate cancer (mHSPC), approving the radioligand in combination with an androgen receptor pathway inhibitor (ARPI) for PSMA-positive disease. The move nearly doubles the eligible population for Pluvicto, placing the therapy earlier in the prostate cancer timeline. Regulators based the approval on the Phase 3 PSMAddition trial (NCT04720157). In the study, Pluvicto plus ARPI/ADT reduced the risk of progression or death versus standard of care, with an updated analysis showing a further benefit. Safety reflected the known Pluvicto profile. A companion regulatory item highlighted separate FDA priority-review action for a related subcutaneous EGFR/MET approach in head and neck cancer, supported by OrigAMI-4 results. Together, the approvals underscore continued momentum in precision oncology that pushes targeted radioligands and dual-pathway biologics earlier or deeper into treatment pathways.