Novartis opens third US radioligand manufacturing facility

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Novartis has opened its third manufacturing facility for radioligand therapies, with a new site in Carlsbad, California joining existing locations in Florida and Texas.

The move is part of the Swiss pharma company’s $23 billion US expansion plan and designed to meet future radiopharmaceutical demand with a focus on the western US, Alaska and Hawaii.

Proximity to treatment centres is a vital consideration with radioligand therapies because each dose has to be custom-made and once manufactured its administration becomes time-sensitive, with a radioactive half-life that is measured in hours.

Vas Narasimhan, CEO of Novartis, said: “Radioligand therapy is a breakthrough we’ve unlocked at scale, made possible by reimagining how innovation reaches patients. As the global leader in RLT for more than seven years, we’ve advanced this technology with a deep belief in its power to transform cancer care.

“The opening of our Carlsbad facility underscores our strong commitment to the US and dedication to bringing this pioneering treatment to patients across the country.”

The new 10,000-square-foot manufacturing facility has been filed with the FDA as an additional US point of supply and poised to begin operations once the regulator approves its use.

Novartis’ prostate cancer radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) first won approval from the US Food and Drug Administration (FDA) in 2022.

An intravenous radioligand therapy, Pluvicto combines a targeting ligand compound with a therapeutic radionuclide, the radioactive particle lutetium-177.

The treatment’s US licence was expanded in March this year with an indication for use before chemotherapy in prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

The pharma company also has ongoing clinical trials of radioligand therapies in prostate cancer, breast, colon, lung, brain, pancreatic and other cancers, as part of a pipeline that includes Lutathera (lutetium Lu 177 dotatate), approved in 2018 for gastroenteropancreatic neuroendocrine tumours.

The opening of the Carlsbad site comes amid a sustained from the US to persuade pharma companies to onshore their manufacturing capabilities, a drive that has seen billions of dollars of investment from firms such as GSK, J&J, AstraZeneca and Lilly.

Commenting on the latest pharma US investment to come to fruition, FDA Commissioner Marty Makary said: “We commend Novartis for supporting our broader mission of bringing manufacturing capacity in the United States. Our unique partnership approach is working.”