FDA Approves New Pluvicto Production Facility in Indianapolis

January 5, 2024

Today Novartis announced that it has received FDA approval for its radioligand therapy manufacturing facility in Indianapolis, Indiana, for commercial manufacturing of Pluvicto (177Lu-vipivotide tetraxetan).

Given the rapidly growing demand for the therapy and past challenges with supply of the radiopharmaceutical, SNMMI applauds the approval.

Pluvicto is a lifesaving PSMA-targeted nuclear medicine therapy for prostate cancer that is currently used in patients with late-stage disease. These patients have few, if any, options left for effective therapy, so access and adequate supply are critically important.

In spring 2023, a supply problem with Pluvicto led to delays of 3 months or longer for new patients. In October, the FDA classified the drug shortage status as resolved; Novartis announced that production in its Ivrea, Italy, and Millburn, New Jersey, plants was up to speed and supply was “unconstrained.” Approval of the new Indianapolis production site will help ensure that supply is sufficient to meet the increasing demand and readily available to patients.

The full Novartis announcement is available here.