BASEL (dpa-AFX) - Novartis (NVS) announced that the U.S. Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The approval is supported by results from the Phase III PSMAddition trial, which showed that Pluvicto reduced the risk of progression or death by 28 percent when added to standard of care compared to standard of care alone. In a subsequent updated analysis, the combination further reduced the risk of progression or death by 33 percent, with a positive overall survival trend favoring Pluvicto plus standard of care as data continue to mature ahead of the final OS analysis.
With this approval, Pluvicto can now be used across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population.
Pluvicto remains the only PSMA-targeted therapy approved across metastatic prostate cancer. Novartis is also investigating its potential in oligometastatic prostate cancer.
NVS closed Friday's regular trading at $156.15 down $2.29 or 1.45%.
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