Posted by Michael Wonder on 31 Jul 2026
FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
31 July 2026 - Today, the FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).
Efficacy was evaluated in PSMAddition, a randomized, multicenter, open-label trial in patients with PSMA-positive mAPMN/S prostate cancer.
