Amid Pluvicto shortage, FDA quickly clears Novartis manufacturing facility

After a shortage prevented prostate cancer patients from getting Novartis’ Pluvicto, the FDA has quickly approved a radiotherapy manufacturing facility to help the company ramp up commercial supply.

The FDA has approved a Novartis radioligand therapy manufacturing facility in Millburn, New Jersey, to supply Pluvicto for commercial use in the U.S., Novartis said Friday.

The signoff is a much-needed win for Novartis and for the many late-line prostate cancer patients waiting for the treatment. Novartis recently put new patient starts for Pluvicto on hold as demand exceeded the company’s expectations. Doctors also complained about existing patients having their doses delayed multiple times.

Novartis wouldn’t specify a timeline as to when it will restart new patients on Pluvicto. In a statement to Fierce Pharma, a Novartis spokesperson said the company is talking to doctors and treatment centers “to help them understand how the gradual increase of supply will impact existing and new orders, as well as our expectations for scheduling into the second half of the year.”

Production at the new Millburn site “will begin in the coming weeks and ramp up gradually,” Novartis said in a press release, suggesting it might take some time before supply constraints can be resolved.

“The site is expected to contribute meaningfully to supply and sales in the third quarter, after the anticipated approval of additional lines at the site,” Novartis added in the release. “Capacity should continue to increase through the second half of this year, helping to ensure stable, reliable supply to patients.”

The estimated duration of the Pluvicto shortage was about three months, according to an FDA update earlier this month.

The shortage apparently gave the FDA a sense of urgency. Rather than a standard four-month review timeline, the FDA approved the Millburn site in less than two months.

Since Pluvicto’s FDA approval for previously treated, PSMA-positive metastatic castration-resistant prostate cancer last March, Novartis has been supplying the radiotherapy from a facility in Ivrea, Italy. That European site will continue to make Pluvicto for the U.S. market, and further capacity expansions are underway, Novartis said.

Novartis expects to open a new facility in Indianapolis, Indiana, at the end of this year at the earliest. Another site in Zaragoza, Spain, has won approval to supply the drug to the EU market.

All told, Novartis is targeting at least 250,000 doses of Pluvicto supply annually by 2024 and beyond.

Novartis has high hopes for Pluvicto and its radiopharmaceutical portfolio in general. The company has put Pluvicto’s peak sales projection at above $2 billion based on its potential to move into earlier treatment lines.