Following a shortage that led it to curb dose distribution, Novartis has scored FDA approval to manufacture Pluvicto (177Lu-PSMA-617) at its Millburn, New Jersey facility, which will enable it to avoid production issues and delays in transport that have prevented providers from using the radiopharmaceutical to treat prostate cancer patients.

Approved by the FDA in 2022, Pluvicto treats metastatic castration-resistant prostate cancer in patients who have already undergone standard-of-care treatments such as androgen receptor pathway inhibition and chemotherapy, and has been proved to increase overall survival.

It combines a targeting compound or ligand with a radioactive particle, and emits a small amount of ionizing beta radiation to the tumor from a short distance away to avoid hitting surrounding healthy tissue.
The company filed an expedited review with the FDA in February to approve the plant as a U.S. source for Pluvicto production, and is now drawing up plans to ramp up production there in the next few weeks and begin shipping from there.

Until now, it has produced the radiopharmaceutical only at its plant in Ivrea, Italy, which will continue to supply the U.S. market, but “unplanned manufacturing events” and “doses not arriving in time” led to a shortage in supplies, with orders that arrived after five days unusable, causing providers to reschedule patients and push back waiting lists.

This led the company in March to announce that it would stop delivering regimens for new patients, and only provide supplies for those who had already begun their treatment.

“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,” said Novartis in a statement.

The company is also expanding its Italian site, expects to open another facility in Indianapolis by the end of this year, and has received approval for its site in Zaragoza, Spain, which will supply the EU market, with production to ramp up there over the next few months. All four together are expected to produce at least 250,000 doses of Pluvicto annually by 2024.

“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,” said the Society of Nuclear Medicine and Molecular Imaging in a statement.

During Novartis’ Pluvicto shortage the association encouraged providers to treat patients in Phase 3 clinical trials for SPLASH (NCT0464752, POINT Biopharma/Lantheus) and ECLIPSE (NCT05204927, Curium), saying that they “may be the only way” that new metastatic prostate cancer patients eligible for Pluvicto could receive treatment in the U.S. during the shortage.

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