Core Concepts
Manufacturing and delivery issues lead to a shortage of a crucial prostate cancer treatment, impacting patient care.
Abstract
The content discusses the shortage of the radioligand treatment lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for metastatic castration-resistant prostate cancer patients.
FDA reports manufacturing and delivery issues affecting the availability of Pluvicto.
Novartis, the drug manufacturer, prioritizes existing patients over new orders due to limited supply.
Production challenges in Italy and plans to increase production in the US over the next 12 months.
Quality issues in the manufacturing process led to supply problems last year.
Patients awaiting their first dose of Pluvicto will need to be rescheduled, impacting treatment timelines.
Concerns raised by experts about potential negative outcomes for patients due to the shortage.
Stats
Novartis is prioritizing patients who have already started the regimen due to limited supply.
The manufacturer will not be taking any orders for new patients for the next 4 to 6 months.
Pluvicto has a 5-day window to reach patients after production.
The company is working to increase production capacity and supply over the next 12 months.
Quotes
"People will die from this shortage, for sure." - Jonathan McConathy, MD, PhD