Novartis expands Pluvicto manufacturing footprint with FDA blessing of Indianapolis radiotherapy facility

Novartis has been compensating for a temporary shortage of Pluvicto with aggressive expansion of manufacturing capacity. Now, the Swiss pharma is initiating a new commercial radiotherapy facility billed as “the company’s largest and most advanced in the world.”

The new plant, located in Indianapolis, has won FDA approval to churn out commercial doses of Pluvicto, Novartis said Friday. Before the go-ahead, the site had been making Pluvicto for clinical trials, a Novartis spokesperson told Fierce Pharma.

The 70,000-square-foot facility was specifically built to make radioligand therapies, which represent a key focus at Novartis. The physical space allows for continued line expansion and plans for fully automated lines, marking a first in the radiopharmaceutical industry, Novartis said.

With the addition of the Indianapolis site, Novartis now has capacity to make 250,000 doses of radiotherapies annually in 2024 and beyond. It has more than enough supply to treat patients within two weeks of diagnosis, the company noted.

Novartis’ radiotherapy production network also includes a Millburn, New Jersey, plant that the FDA cleared to produce Pluvicto for commercial use in April 2023. A site in Ivrea, Italy, has also been supplying the prostate cancer treatment to patients inside and outside the U.S., while a facility in Spain handles ex-U.S. demand.

Further expansions are on the way. Novartis recently unveiled an $85 million plan to build a new radiotherapy facility in China to potentially supply doses for the country starting in 2026. In November, Novartis’ Japan unit said it will invest $100 million in a factory in Sasayama to support radioligand therapy production.

First approved by the FDA in March 2022, Pluvicto quickly became a much-needed option for heavily pretreated patients with PSMA-positive metastatic castration-resistant prostate cancer. Demand exceeded Novartis’ expectations, leading to months of shortages and a halt of new patient starts in early 2023.

With the Millburn facility's launch, Novartis had achieved unconstrained supply for Pluvicto, CEO Vas Narasimhan told investors during the company’s third-quarter earnings call in October. During that quarter, Pluvicto pulled in $256 million in sales, compared with $240 million in the three months prior.

“By early Q1, commercial production at the Indianapolis site will further strengthen our supply chain capacity and prepare for future increased demand,” Novartis' spokesperson said on Friday.

Novartis has figured Pluvicto could eventually reach more than $3 billion in peak sales if its late-stage development pans out. But a key market expansion plan recently hit a hiccup, bringing into question whether the scale of the manufacturing buildup is necessary, at least for now.

The PSMAfore trial, which was designed to move Pluvicto earlier in the treatment sequence before chemo, hit its progression-free survival goal, but an interim analysis also suggested an early negative trend in overall survival.

Given that the overall survival readout was immature, Novartis has decided to wait for another data analysis before finalizing regulatory submissions. The company still expects to file with health authorities this year.

In addition, the phase 3 PSMAddition trial that’s evaluating Pluvicto in patients with hormone-sensitive metastatic prostate cancer is expecting a primary endpoint analysis in 2025. Novartis also has a pipeline of other radioligand therapies targeting various cancer types.