Novartis Gets Another Facility OK’d for Pluvicto

FDA has approved Novartis’ Radioligand Therapy (RLT) manufacturing facility in Millburn, NJ to manufacture prostate cancer therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan), which has been on the agency’s drug shortage list.

“Production will begin in the coming weeks and ramp up gradually,” Novartis says. “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. Capacity should continue to increase through the second half of this year, helping to ensure stable, reliable supply to patients. The RLT manufacturing facility in Ivrea, Italy, will continue to supply the U.S. market, and further capacity expansion is underway at the site.”

Pluvicto is approved for treating adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.