FDA Approves Novartis' Pluvicto for Earlier-Stage Prostate Cancer, Finishing Review a Month Early

The FDA approved Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for adults with PSMA-positive metastatic prostate cancer in an earlier treatment setting, the company said August 3. The approval — completed a month ahead of the target action date — expands the PSMA-targeted radioligand therapy from late-stage disease to patients who have not yet received systemic therapy for metastatic disease.

The Data

The decision rests on the Phase 3 PSMAddition trial, which enrolled 1,144 patients and showed a statistically significant 28% reduction in the risk of radiographic disease progression or death (hazard ratio 0.72; p=0.002) versus ARPI therapy alone. Under the label, patients must first undergo PSMA PET imaging — such as with Novartis' Locametz — to confirm their tumors express PSMA before receiving the therapy.

Moving Pluvicto earlier in the treatment line changes the calculus for metastatic prostate cancer: patients now gain an option that delivers targeted radiation to PSMA-positive disease at the moment systemic therapy begins.

What It Means

Pluvicto is the flagship of Novartis' radioligand therapy franchise, and the label expansion gives it access to a substantially larger patient pool. The accelerated review also continues a busy FDA stretch that included the first gene therapy for young children with sickle cell disease and the first oral PCSK9 inhibitor for high cholesterol in July, as the agency shifts from framework-building to execution.