FDA has expanded the use of Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) earlier in metastatic prostate cancer care, approving the radioligand in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) in combination with an androgen receptor pathway inhibitor (ARPI). The decision is based on the phase 3 PSMAddition trial (NCT04720157), where Pluvicto plus ARPI and ADT reduced the risk of progression or death by 28% versus standard of care (HR 0.72). An updated analysis reported further risk reduction (HR 0.67) alongside a positive overall survival trend (HR 0.80), with additional OS data expected to mature. Separately, FDA granted Priority Review to a supplemental biologics license application for J&J’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma after platinum chemotherapy and PD-1/PD-L1 inhibitor treatment. The application is supported by the OrigAMI-4 trial (NCT06385080), reporting a 42% overall response rate, including complete responses in more than one-third of responders, in a setting with limited post-platinum, post-immunotherapy options.