FDA.GOV: FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer

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The U.S. Food and Drug Administration (FDA) has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. The approval is based on results from the Phase 3 PSMAddition trial, which showed the combination significantly improved radiographic progression-free survival compared with ARPI therapy alone, offering a promising new treatment option for eligible patients.

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