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Amid supply challenges, Novartis halts Pluvicto distribution for new patients

by John R. Fischer, Senior Reporter | March 15, 2023
Business Affairs Molecular Imaging
Due to a shortage, Novartis has stopped distributing doses of Pluvicto for new prostate cancer patients.
Healthcare providers have stopped scheduling new patients to receive Pluvicto (177Lu-PSMA-617), a radiopharmaceutical treatment for metastatic prostate cancer, as Novartis faces supply challenges that are hindering its ability to meet demand.

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.

The solution combines a targeting compound or ligand with a radioactive particle, and emits a small amount of ionizing beta radiation to the tumor at a short distance away to avoid hitting surrounding healthy tissue.
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It has been shown to improve overall survival, says the company. But “unplanned manufacturing events” and “doses not arriving in time” have forced it to stop delivering regimens for new patients for three months or longer.

“At this time, our priority is to supply patients who have received their first doses and are currently in the treatment process. This is important to allow patients who have already begun the treatment cycle to appropriately complete their course of therapy. We continue to ship as many doses as we can to treat as many patients as possible and our clinical trial programs are ongoing,” said Novartis in a statement.

Delays make doses unusable
Novartis manufactures the radiopharmaceutical at its facility in Ivrea, Italy. Each Pluvicto dose must be delivered within five days. Should it arrive beyond that period, the dose must be destroyed and the patient rescheduled, pushing back waiting lists.

To solve this issue, in February the company filed an expedited review with the FDA to approve its Millburn, New Jersey facility as a U.S. source for Pluvicto production. But the review would take four to six months, the company projects.

It also is building a new facility in Indianapolis that could be up and running by the end of the year and would add a significant commercial supply of PLUVICTO.

The company previously ceased production of Pluvicto and Lutathera in May 2022 at its facility in Italy for two months following the discovery of quality issues in the manufacturing process, limiting product supplies available to care teams and their patients.

Finding another solution
In a letter, the Society of Nuclear Medicine and Molecular Imaging encouraged providers and patients to look into Phase 3 clinical trials for new compounds such as SPLASH (NCT0464752, POINT Biopharma/Lantheus) and ECLIPSE (NCT05204927, Curium), as these “may be the only way” that new metastatic prostate cancer patients eligible for Pluvicto may receive PSMA-targeted radiopharmaceutical therapy in the U.S. amid the shortage. Similar treatments may also be available in other countries.

The organization is working with Novartis leaders to address the situation and has sent a letter to the FDA about potential options, including speeding up the review for the Millburn site. Along with patient groups, it is petitioning the FDA over the drug shortage and exploring potential tactics to reduce the shortage within the nuclear medicine community.

“SNMMI is very concerned about this situation and will work vigorously to help make lifesaving/life-prolonging radiopharmaceutical therapies available to patients in need,” said the Society of Nuclear Medicine and Molecular Imaging in a statement.

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