Novartis Reports the US FDA Approval of Pluvicto for mHSPC
Shots:
- The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer
- Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC alone
- At an updated analysis, Pluvicto plus SoC reduced the risk of progression or death by 33% & showed a positive OS trend as survival data continue to mature ahead of the final analysis
Ref: Globenewswire | Image: Novartis | Press Release
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