SWITZERLAND – Novartis has resumed the production and delivery of radioligand therapy medicines after fixing the issues that had led to a temporary suspension of production last month.

“The company has remediated the issues that led to the temporary, voluntary suspension of production in May,” the Swiss drugmaker said in a statement, adding these issues did not affect patient safety.

Novartis touted its radioligand earlier this year as a key component in combating competition in the cancer space. However, the physical production of its products has not been without incident, according to Endpoints News.

Novartis had to halt production of its two main radiotherapies, Lutathera and Pluvicto, in May.

Lutathera, an injection for adults with gastroenteropancreatic neuroendocrine tumors, joined Novartis after a US$4 billion acquisition of Advanced Accelerator Applications in 2018 and received FDA approval quickly.

Pluvicto, a therapy for adults with prostate-specific membrane antigen (PSMA) – positive metastatic castration-resistant prostate cancer, was part of Endocyte’s US$2.1 billion acquisition in 2018 and has been touted by Novartis R&D for several years.

The company has reportedly resolved the issues that led to its suspension, and according to Novartis, these issues had no impact on patient safety, and there was no risk to patients from the doses previously produced at these sites.

According to the company, the production halt was done out of extreme caution due to potential quality issues discovered in its manufacturing. The production halt has an impact on the products’ commercial and clinical trial supply.

However, Novartis has restarted production of the two therapies at manufacturing sites in Italy and New Jersey, as well as resumed phased delivery of doses to patients, ahead of the expected six-week timeframe.

The company has reportedly resolved the issues that led to its suspension, and according to Novartis, these issues had no impact on patient safety, and there was no risk to patients from the doses previously produced at these sites.

Novartis is likely relieved that these therapies are back on the production line, as the company has spent tens of millions of dollars to acquire them.

Novartis has several ongoing clinical trials using both Pluvicto and Lutathera that will be impacted by its manufacturing issues, according to the company.

For Pluvicto that includes a pair of phase 3 trials in metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer, while for Lutathera it will affect studies for brain cancer glioblastoma, extensive-stage small cell lung cancer, and new Neuroendocrine tumor (NET) indications.

This news comes at a time when Novartis is planning to cut 8,000 jobs from its 108,000 global workforce as part of a larger global reorganization.

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