Novartis brings radiotherapy production back online, touts expansion plans

Novartis has put an end to a radiotherapy production hiccup, and expansions are already underway.

The drugmaker fixed the quality issues that led to voluntary production halts at its radioligand therapy sites in Ivrea, Italy, and Millburn, New Jersey, Novartis said Thursday. Back in May, the manufacturing freeze abruptly stopped U.S. supply of two of the company’s marketed cancer drugs, Lutathera and Pluvicto.

The company resumed production at the facilities in early June and has since been delivering doses of the products to patients in a phased approach. At this point, Novartis has yet to reach full capacity, and it expects supply to be limited for some time.

The problems at the Italian and New Jersey sites were unrelated, a Novartis spokesperson told Fierce Pharma.

At Ivrea, an “analysis of routine environmental monitoring” triggered a review, the spokesperson said. The company then implemented “corrective actions … to bring the manufacturing area back into compliance with Good Manufacturing Practices.”

As for Millburn, the problem was tied to “how the site performs routine laboratory testing,” the spokesperson said. These issues didn’t affect patient safety, and Novartis didn’t identify any risks for prior drug doses, the company said.

Before the surprise production suspension, the FDA dinged the Millburn facility with a Form 483 for its failure to alert customers about product batches that failed to meet quality standards. The voluntary production suspension wasn’t connected to the Form 483, the Novartis spokesperson said. 

Meanwhile, the manufacturing setback doesn’t seem to affect Novartis’ overall interest in radioligand therapies, a key technology platform underlying the company’s growth strategy. Prostate cancer drug Pluvicto, approved by the FDA in March, carries blockbuster sales expectations.

To meet increased demand for radioligand therapies amid Pluvicto’s launch, Novartis says it's expanding production capabilities at both the Millburn and Ivrea sites. At the Ivreawith sie, Novartis looks to increase capacity with a new roughtly 25,000-square-foot building, and the expansion at the existing Millburn site will feature two additional production lines, a company spokesperson said.

What’s more, back in 2020, Novartis unveiled a plan to erect a second U.S. radiotherapy manufacturing plant at Indianapolis’ Purdue Research Park. With 50,000 square feet of production space, the project is expected to begin operations in 2023.

The unexpected production halt at the critical time of Pluvicto’s launch was clearly a valuable lesson for Novartis.

“We strongly value business continuity planning and are always looking to make our operations more resilient in the event of unforeseen circumstances,” the Novartis spokesperson said, adding that the company is also evaluating potential partnerships to create backup capacity.

Editor's note: The story has been updated with additional information on Novartis' planned expansions at the Millburn and Ivrea sites.