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Novartis Announces FDA Approval for New Jersey Facility to Produce Pluvicto for Commercial Use
April 21, 2023
Today Novartis announced that it has received FDA approval to supply Pluvicto from its plant in Millburn, New Jersey. The company is planning to ramp up production in the coming weeks.
SNMMI acknowledges the FDA’s swift action in addressing this challenging situation and is grateful that Novartis has been able to secure permission to proceed, as this has affected the management plans of numerous prostate cancer patients.
The society will continue to work with the FDA and Novartis and will share more information as it becomes available.
The full announcement follows:
Novartis has received US Food and Drug Administration (FDA) approval to begin supplying Pluvicto for US commercial use from the Novartis Radioligand Therapy (RLT) manufacturing facility in Millburn, New Jersey. Production will begin in the coming weeks and ramp up gradually. The site is expected to contribute meaningfully to supply and sales in the third quarter, after the anticipated approval of additional lines at the site. Capacity should continue to increase through the second half of this year, helping to ensure stable, reliable supply to patients. The RLT manufacturing facility in Ivrea, Italy, will continue to supply the US market, and further capacity expansion is underway at the site.
A new facility in Indianapolis, Indiana, is nearing completion, and is expected to open as soon as the end of this year. In addition, Novartis has received approval for the Zaragoza, Spain, site to supply the EU market. We expect this site to ramp up gradually over the coming months.
With these sites, a capacity of at least 250k doses of Pluvicto annually is targeted in 2024+.
Click here to view Novartis’s letter to healthcare providers.