Published January 9, 2024

Novartis is addressing a temporary shortage of Pluvicto by significantly expanding its manufacturing capabilities. The Swiss pharmaceutical company has unveiled a new commercial radiotherapy facility in Indianapolis, marked as its largest and most advanced globally, receiving FDA approval for the production of commercial doses of Pluvicto. Previously dedicated to Pluvicto production for clinical trials, the 70,000-square-foot facility is designed for radioligand therapies, a focal point for Novartis.

This state-of-the-art facility enables continuous line expansion and plans for fully automated lines, setting a precedent in the radiopharmaceutical industry. With this addition, Novartis anticipates the capacity to manufacture 250,000 doses of radiotherapies annually from 2024 onward, ensuring an abundant supply capable of treating patients within two weeks of diagnosis.

Novartis’ radiotherapy production network extends to a Millburn, New Jersey, plant, cleared by the FDA for Pluvicto commercial production in April 2023. The Ivrea, Italy, site supplies the prostate cancer treatment globally, while a facility in Spain caters to non-U.S. demand.

Further expansion plans are underway, with an $85 million investment in a new radiotherapy facility in China and a $100 million investment in a Sasayama factory in Japan. Pluvicto, initially FDA-approved in March 2022, garnered substantial demand, causing shortages and a pause in new patient starts in early 2023.

Novartis aims to fortify its supply chain with the commercial production launch at the Indianapolis site in early Q1. The company envisions Pluvicto achieving over $3 billion in peak sales, contingent on successful late-stage development. However, challenges arose with the PSMAfore trial, indicating a potential need for a manufacturing scale reassessment. The trial, designed to position Pluvicto earlier in treatment, met its progression-free survival goal but showed an early negative trend in overall survival in interim analysis.

Awaiting further data analysis, Novartis plans to finalize regulatory submissions this year. The phase 3 PSMAddition trial, evaluating Pluvicto in patients with hormone-sensitive metastatic prostate cancer, expects a primary endpoint analysis in 2025. Novartis continues to advance its radioligand therapy pipeline targeting diverse cancer types.