Expanded Pluvicto production gets FDA go-ahead

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Commercial manufacturing of Novartis’ radioligand therapy Pluvicto^TM (INN: lutetium (¹⁷⁷Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

The 70,000ft² site facility in Indianapolis, Indiana, US, facilitates substantial supply increases “for the foreseeable future”, Novartis noted.

“The intricate process of providing radioligand therapy to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” stated Steffen Lang, President of Operations at Novartis.

The Indianapolis facility has space for continued line expansion. Novartis confirmed that this includes plans for fully automated lines, which is a “first” for the radiopharmaceutical industry.

Upon approval, Novartis’ facility in Ivrea in Italy will continue to supply patients in and outside the US. The company’s site in Zaragoza, Spain will provide radioligand therapy for patients outside the US. The new site and Novartis’ New Jersey location will supply the growing demand for US patients and later, in Canada.

Ensuring adequate supply of radioligand therapy

According to a statement by Novartis, with supply of Pluvicto unconstrained, the pharmaceutical company has doubled weekly production of the medicine. At present, it has “more than sufficient supply to treat patients within two weeks of diagnosis.”

The company also declared that it plans to add more sites for Pluvicto and Lutathera^® (INN: lutetium (¹⁷⁷Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) closer to patients over the coming months.

Novartis highlighted that with its four active manufacturing facilities, and a radioligand therapy production capacity of 250,000 doses in 2024 and beyond, this can support current and future demand, seeing that ongoing clinical trials may bring about the need to provide Pluvicto and Lutathera to more patients in earlier lines of treatment.

This production expansion follows Novartis’ announcement in September 2023 that its radioligand therapy Lutathera (INN: lutetium (177Lu) oxodotreotide /lutetium Lu 177 dotatate) was the first to demonstrate clinically meaningful benefit in a first line setting, as seen in a Phase III trial.

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