FDA resolves drug shortage for Novartis’ prostate cancer drug Pluvicto

Novartis has announced that the FDA has resolved the drug shortage status for Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The development comes after Novartis significantly scaled up production, more than doubling its weekly production capacity since May. 

The company initially halted production of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) along with Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide in the U.S. and Canada in mid-2022 over possible quality concerns. The company restarted production soon thereafter. 

Pluvicto is a radiopharmaceutical medication for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. Lutathera is indicated for gastroenteropancreatic neuroendocrine tumors. 

Burgeoning demand for Pluvicto

Pluvicto is approved in the U.S., the European Union, and other countries to treat adults with advanced PSMA-positive metastatic castration-resistant prostate…

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