March 20, 2023
Due to severe production issues, the supply of Pluvicto is not currently sufficient to meet patient need. Demand will not be met until new production facilities are brought fully online.
Pluvicto is a lifesaving prostate cancer radioligand therapy currently used in patients with late-stage disease. These patients have few, if any, options left for effective therapy. Unfortunately, with the current shortage, therapy doses are frequently cancelled, and therapy can be delayed for months. This situation can be catastrophic for patients, and some will not survive the delay.
SNMMI is pursuing several pathways to help resolve this crisis, including:
Please note: 223Ra-dichloride (Xofigo; Bayer) is an option for treating bone metastases in patients with metastatic castration-resistant prostate cancer.
SNMMI is very concerned about this situation and is working vigorously on additional measures to help make lifesaving/life-prolonging radiopharmaceutical therapies available to patients in need. Stay tuned for further communications from the society.
SNMMI urges the nuclear medicine community to contact the FDA as soon as possible to respectfully urge the agency to expedite review of the Novartis facility in Milburn, New Jersey. A sample letter is available HERE for your convenience.
The FDA approved Pluvicto [177Lu-vipivotide tetraxetan; Novartis] in March 2022 to treat metastatic castration-resistant prostate cancer. The therapy was shown to significantly improve overall survival.
A supply problem with Pluvicto has led to shortages resulting in a delay of 3 months or longer for new patients, which is having a profound negative impact on patient care.
Currently, only one site (Novartis facility in Ivrea, Italy) is approved by the FDA to manufacture 177Lu-PSMA-617 for commercial use, and it cannot produce enough product to meet patient’s needs. Novartis’s manufacturing site in Millburn, NJ, can produce Pluvicto for use with research patients and has applied for expedited FDA review for commercial production; if approved, the review would take 4-6 months. In addition, Novartis is building a new manufacturing facility for Pluvicto in Indianapolis, which they expect will be operational by the end of 2023. In order to meet demand, both of these facilities must be fully operational.
Novartis is prioritizing patients who have received at least one dose and are currently in treatment, followed by those who are in the scheduling system awaiting their first dose. The company has stated that it will not accept new patient starts until the Millburn, NJ, manufacturing site is approved by the FDA, which they project will take 4 to 6 months.