Novartis has received FDA approval to begin supplying Pluvicto for US commercial use from the Novartis Radioligand Therapy (RLT) manufacturing facility in Millburn, New Jersey. This is an important step forward. Production will begin in the coming weeks and gradually ramp up. The site is expected to contribute meaningfully to supply in the third quarter after the anticipated approval of additional lines. Capacity should continue to increase through the second half of this year, helping to ensure a stable, reliable supply to patients. The RLT manufacturing facility in Ivrea, Italy, will continue to supply the US market.
What this approval means for patients in the short term:
Novartis is actively working with physicians in treatment centers administering Pluvicto to coordinate the scheduling of patient treatments.
With a gradual increase in new supply, Novartis expects to reduce the current issues that have led to treatment cancellations.
Over time, patients who previously could not start on Pluvicto may be able to schedule a treatment with their healthcare providers.
What this means for Pluvicto supply in the long-term:
The approval of the Millburn facility is a first step. Novartis promises to do its best to deliver orders consistently while its RLT production capacity scales up.
A new facility in Indianapolis, Indiana, is nearing completion and is expected to open as soon as the end of this year, and capacity at the existing European facilities in Ivrea, Italy, and Zaragoza, Spain, is being expanded.
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