FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
RegulatoryapprovedPluvictoPositive
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Summary
The FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) on July 31, 2026, in combination with androgen receptor pathway inhibitor therapy for adults with PSMA-positive metastatic prostate cancer. This approval represents a significant regulatory milestone for Novartis in oncology.
Outcome Details
FDA approval of Pluvicto in combination with ARPI therapy for metastatic prostate cancer
Importance:9/10
Sentiment:
0.95
FDA approvaloncologyprostate cancerradiopharmaceuticalcombination therapy
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Published by FDA Drugs (New Approvals & NDA) on August 3, 2026 11:21 AM