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FDA declares Novartis' Pluvicto shortage over and that supply will grow in 2024

por John R. Fischer, Senior Reporter | October 31, 2023
Business Affairs Molecular Imaging
Novartis' 177Lu-PSMA-617 (Pluvicto)
The FDA has said the Pluvicto (177Lu-PSMA-617) shortage that began earlier this year is officially over and that the supply of the intravenous radioligand therapy manufactured by Novartis will continue to grow in 2024.

Approved by the FDA in 2022, Pluvicto treats metastatic prostate cancer in patients who have already undergone androgen receptor pathway inhibition, chemotherapy, and other cancer treatments, 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.

Novartis, which manufactures the radiopharmaceutical at its Millburn, New Jersey facility, said back in March that unplanned manufacturing events and doses not arriving in time forced it to stop providing regimens for new patients and reserve all available doses for those currently undergoing treatment.
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It now says that these issues have been resolved and that it has doubled weekly production since May and has more than enough supplies to treat patients within two weeks of diagnosis.

“We have been working hard to increase the capacity and improve the reliability of the supply of our radioligand therapies to ensure patients have access to this therapy and to prepare for future growth as more patients may become eligible for this treatment,” said Victor Bulto, president of Novartis U.S., in a statement.

The company plans to expand capacity at its production lines in New Jersey and its new state-of-the-art RLT (radioligand therapy) facility in Indianapolis, Indiana, where the company is currently awaiting FDA approval to manufacture commercial doses and has already started clinical production.

It also has partnered with treatment sites to add more than 200 facilities in the U.S. that are certified to administer the company’s RLTs and plans to onboard approximately 130 more. Its RLT manufacturing facility in Ivrea, Italy will continue to supply patients in and outside the U.S. while the facility in Zaragoza, Spain will solely supply patients outside of the U.S.

Together, with its four facilities worldwide, it predicts that it will produce at least 250,000 RLT doses in 2024 and beyond.

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