FDA approves Pluvicto manufacturing at U.S. facility

Novartis has received approval from the U.S. Food and Drug Administration to manufacture its prostate cancer drug Pluvicto at its new plant in Indianapolis, Indiana.

The 70,000-sq-ft site is the company’s second U.S. location and is designed specifically for radioligand therapy (RLT) manufacturing and is expected to boost the supply of the drug for the foreseeable future, the company said.

Pluvicto (lutetium-177 [Lu-177] prostate-specific membrane antigen [PSMA]-617) is indicated for adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have previously received other anticancer therapies. PSMA-PET scans are used to identify candidates who may be eligible for the drug, the company added.

Page 1 of 436
Next Page