FDA Approval Nearly Doubles Eligible Patient Pool For Novartis' Pluvicto - Novartis (NYSE:NVS)

Arkansas Board of Pharmacy voted to suspend enforcement of Act 630, a 2025 law restricting manufacturers’ limited drug distribution networks to favor in-state pharmacies. A federal court preliminarily enjoined enforcement against Novartis, citing likely unconstitutional discrimination under the Dormant Commerce Clause. After Bristol Myers Squibb sued and the AG said the act is likely unconstitutional, the Board authorized settlement and non-enforcement.

The FDA approved Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) plus an ARPI for adults with PSMA-positive metastatic mAPMN/S prostate cancer. In the phase 3 PSMAddition trial (N=1144), Pluvicto+ARPI cut risk of radiographic progression or death by 28% vs ARPI alone (HR 0.72, P=.002). Updated analysis showed 33% risk reduction (HR 0.67).

The FDA approved Novartis’ Pluvicto (lutetium Lu-177 vipivotide tetraxetan) for PSMA-positive metastatic hormone-sensitive prostate cancer, to be used with an androgen receptor pathway inhibitor and androgen deprivation therapy. Based on the PSMAddition phase 3 trial, radiographic PFS improved (HR 0.72). OS data are immature, and grade 3+ adverse events were higher (50.7% vs 43%).

The FDA approved Novartis’ lutetium Lu 177 vipivotide tetraxetan (Pluvicto) with ARPI therapy for adults with PSMA-positive metastatic prostate cancer that is androgen pathway modulation-naive or -sensitive. The expanded indication nearly doubles eligible patients. In the PSMAddition trial (n=1,144), Pluvicto cut radiographic progression or death risk by 28% (HR 0.72, P=0.002).

The FDA expanded the label for Novartis’ radiopharmaceutical Pluvicto, approving it for use with hormone therapy for a broader group of metastatic prostate cancer patients. The change is described as nearly doubling the eligible patient population, according to the FDA and Novartis.

Novartis said the US FDA approved Pluvicto with an androgen receptor pathway inhibitor for metastatic hormone-sensitive prostate cancer (mHSPC). Based on the phase 3 PSMAddition trial, the combo cut progression or death risk by 28% versus standard of care, and an updated analysis showed a 33% reduction with a positive overall survival trend. The label now covers all PSMA-positive metastatic prostate cancer stages, nearly doubling eligible patients.