Tokyo (SCCIJ) – The Swiss pharmaceutical giant Novartis has opened a new manufacturing facility for its revolutionary radioligand cancer therapy in California. It is more effective with fewer side effects than traditional radiotherapy.
“Therapy breakthrough”
The opening of the 10,000-square-foot facility in Carlsbad, California, allows Novartis to add additional capacity for its radioligand cancer therapy. Commercial manufacturing will begin once the US Food and Drug Administration approves the site. Novartis is the only pharmaceutical company with a dedicated commercial radioligand therapy portfolio, and the Carlsbad facility is its third US manufacturing site.
Radiotherapy is usually delivered from outside the body to kill tumor cells, but this process also damages healthy tissues. Radioligand therapy administers an intravenous infusion containing radioactive isotopes attached to a ligand. These molecules bind to receptors on cancer cells. Hence, the radiation dose hits primarily the tumor. As each dose is custom-made and a radioactive half-life measured in hours, proximity to treatment centers and transit hubs helps ensure patients receive their treatment when and where they need it.
“Radioligand therapy is a breakthrough we’ve unlocked at scale, made possible by reimagining how innovation reaches patients,” said Vas Narasimhan, CEO of Novartis. The Swiss company’s pipeline contains seven potential radioligand therapies in 15 clinical trials and more in pre-clinical testing. The Swiss drug maker received US approval for its prostate cancer drug Pluvicto in 2022 and has since expanded into treating patients with earlier-stage disease. CEO Narasimhan estimates the market size at 25–30 billion dollars.
Safety challenges
Novartis became a pioneer in radioligand therapy after acquiring the technology in two deals. In 2017, it bought Advanced Accelerator Applications, founded by scientists from CERN (the European Organization for Nuclear Research), followed by a 2.1-billion-dollar deal for US biotech Endocyte the next year. The Financial Times reported that scans from the new targeted form of radiotherapy amazed doctors and drug developers because they showed the tumors shrinking. For some patients in the clinical trial, the therapy had completely cleared cancer that had spread around their bodies in just six months.
However, Novartis faced some challenges. It must handle, manufacture, and deliver the radioisotopes safely. At its campus in Basel, Novartis reinforced the central radioligand laboratory with 40 tons of lead. The pharmaceutical maker had to acquire much of the supply of the radioactive isotope lutetium to manufacture the drugs on a large scale; Russia is the primary source. Novartis is now searching for drugs that bind to genetic mutations common in tumors to treat other cancers.
Text: SCCIJ based on Novartis material
