Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan injection) is currently in shortage due to challenges in meeting demand and no therapeutic equivalents being available, according to the Food and Drug Administration (FDA).
Pluvicto is a radioligand therapeutic agent indicated for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
Novartis is currently manufacturing small batches of Pluvicto in a facility in Italy, with only a 5-day window for each dose to reach its intended patient (shelf life is 120 hours from the date and time of calibration). To increase production capacity and supply, the Company intends to open 2 new manufacturing sites in the US over the next 12 months. As a result, new orders of Pluvicto will not be accepted at this time.
In a statement, the Company noted that patients who have initiated the treatment cycle will be prioritized to appropriately complete their course of therapy. Patients who are currently in the scheduling system and waiting for their first doses will need to be rescheduled.
Pluvicto is supplied as a 30mL single-dose vial containing 1000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan.
- Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection. FDA Drug Shortages. Accessed March 9, 2023. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Lutetium+Lu+177+Vipivotide+Tetraxetan+%28Pluvicto%29+Injection&st=c&tab=tabs-4&panels=0.
- Novartis update for patients on supply of Pluvicto™. News release. Novartis Pharmaceuticals Corporation. February 23, 2023. Accessed March 9, 2023. https://www.fda.gov/media/165964/download.