FDA approves supplement 37 for Novartis's Pluvicto

The FDA has approved a new efficacy supplement for Pluvicto (lutetium Lu-177 vipivotide tetraxetan), the radioligand therapy sponsored by Novartis. The application is listed as NDA 215833 supplement number 37, with a submission class of Efficacy and a submission status of AP (approved).¹

The product is an intravenous solution with a strength of 27mCi/ML.¹ The review priority for this submission was standard.¹

The submission status date is listed as 2026-07-31.¹ Associated application documents include an approval letter dated August 4, 2026, and an updated product label also dated August 4, 2026.¹

The FDA record does not specify what clinical data or new indication supported this efficacy supplement, nor does it detail specific changes to the product labeling beyond noting that an updated label was issued alongside the approval. Readers seeking the substantive basis for this supplement, such as new trial results, expanded indications, or dosing changes, would need to consult the underlying approval letter and label documents directly, as those specifics are not contained in the available FDA database entry.

This approval adds to the regulatory history of Pluvicto, which has undergone multiple supplemental submissions since its original approval as tracked under application number NDA215833.