March 31, 2022 – Imaging Endpoints congratulates Novartis for its recent Food and Drug Administration (FDA) approval of Locametz® and Pluvicto™. The FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). On the same day, the FDA approved Locametz (gallium Ga 68 gozetotide), a radioactive diagnostic agent for PET of PSMA-positive lesions, including selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated. Locametz is the first radioactive diagnostic agent approved for patient selection in the use of a radioligand therapeutic agent.
Patients with previously treated mCRPC should be selected for treatment with Pluvicto using Locametz or another approved PSMA-11 imaging agent based on PSMA expression in tumors. PSMA-positive mCRPC was defined as having at least one tumor lesion with gallium Ga 68 gozetotide uptake greater than normal liver. Patients were excluded from enrollment if any lesions exceeding certain size criteria in the short axis had uptake less than or equal to uptake in normal liver.
Efficacy was evaluated in VISION, a randomized, multicenter, open-label trial that evaluated Pluvicto plus best standard of care (BSoC) (n=551) or BSoC alone (n=280) in men with progressive, PSMA-positive mCRPC. The trial demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS).
Imaging Endpoints has supported several recent regulatory approvals in prostate cancer and is a leading global expert in the blinded independent central review (BICR) of imaging for prostate cancer clinical trials. In addition, Imaging Endpoints has supported a significant percentage of recent FDA approvals within all oncology new drug applications.