- Novartis on Friday said it has received FDA clearance to begin production of its radiopharmaceutical drug Pluvicto out of its factory in Millburn, New Jersey.
- Novartis has struggled with production of Pluvicto since winning U.S. approval for its use treating prostate cancer in March 2022. Manufacturing setbacks have resulted in delays to patient treatment, forcing Novartis to add additional supply capacity to keep pace with demand.
- Production at the New Jersey site is expected to begin in the upcoming weeks, while manufacturing ramps up at the pharmaceutical company’s other facilities. A new plant being constructed in Indianapolis is nearing completion, Novartis said.
Novartis gained Pluvicto through its $2.1 billion acquisition of Endocyte — part of CEO Vas Narasimhan’s push into radiopharmaceuticals. Novartis has forecast the drug will eventually earn $2 billion annually, and has continued to invest in research and production.
The drug is not easy to make, however. Pluvicto combines a radioactive isotope with a targeting compound called a ligand, so manufacturing is more challenging than other types of medicines. Novartis previously had to halt production due to quality issues that also affected Novartis’ other marketed radiopharmaceutical, Lutathera.
Demand is expected to grow, as Novartis reported late last year results from a clinical trial that could lead to an expanded approval for Pluvicto. The trial, which enrolled patients with metastatic prostate cancer that’s resistant to castration, found the drug helped keep cancer from progressing for longer than did standard treatment.
In preparation, Novartis said it would ramp up manufacturing by adding new factories in Indiana, Italy and New Jersey.
Its site in Ivrea, Italy will continue production for the U.S. and is expected to expand capacity in the future. Novartis additionally gained clearance for a site in Zaragoza, Spain, which will supply the drug in Europe. Its new facility in Indianapolis is close to completion and should be open as early as this year.
Novartis anticipates the New Jersey site will contribute “meaningfully” to the supply and sales of Pluvicto by the third quarter. The company estimates it will be able to produce at least 250,000 doses of Pluvicto annually by 2024.
Novartis is continuing to invest in radiopharmaceuticals in other ways, too. The company recently teamed up with with Bicycle Therapeutics to use the smaller company’s technology to create targeted radiation treatments for cancers.