On March 15, 2023, ASTRO sent a letter to the U.S. Food and Drug Administration (FDA) expressing concern about patient access to Lutetium LU 177 Vipivotide Tetraxetan (Pluvicto) and support for Novartis’ request for expedited review of their Milburn, New Jersey, production facility. Currently, Novartis is shipping doses from their production facility in Italy to the United States. This facility is unable to meet demand, and patients are either not receiving their full treatment, or their treatment is being delayed.

We respect the FDA’s regulatory role in protecting patients by ensuring therapies are safe and effective. However, without a consistent and stable domestic source of Pluvicto, patients cannot receive the recommended course of treatment for this life-extending radiopharmaceutical. We believe that without expedited review and approval of Novartis’ Milburn, New Jersey, production facility, patient care will be compromised.