FDA clears Novartis’ Pluvicto for metastatic hormone-sensitive prostate cancer on July 31, 2024
AI Market Summary
The FDA's approval of Novartis' Pluvicto for metastatic hormone-sensitive prostate cancer expands use into earlier-line therapy, materially increasing the addressable patient pool and commercial runway. Phase III PSMAddition showed a 28% to 33% reduction in progression or death when added to ARPI plus ADT, with overall survival data trending positive but not yet mature. Near-term focus shifts to payer uptake and the final OS readout.
Impact level
● Medium
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The U.S. FDA approved Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for metastatic hormone-sensitive prostate cancer (mHSPC) on July 31, 2024, moving the treatment into an earlier line. The decision was based on the Phase III PSMAddition trial, where adding Pluvicto to an androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy cut the risk of progression or death by 28% in the primary analysis and 33% in an updated analysis. Overall survival trended in favor of the Pluvicto arm, but the data are not yet mature.
