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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Novartis temporarily halts production of two radioligand therapy medicines

Novartis (NYSE:NVS) announced that it had voluntarily stopped the production at radioligand therapy plants in Ivrea, Italy and Millburn, New Jersey, over possible quality concerns.

In a statement, the company explained it had made the decision “out of an abundance of caution due to potential quality issues identified in its manufacturing processes.”

As a result, it will stop the distribution of Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide in the U.S. and Canada, and Pluvicto (lutetium Lu 177 vipivotide tetraxetan).

The company plans to investigate further before resuming the production of the two radioligand therapies.

The company anticipates having some supply of the two drugs in the next six weeks.

In the meantime, the company can continue distributing Lutathera in Europe and Asia from a site in Zaragoza, Spain. Novartis, however, acknowledges that the supply of the drugs may be limited.

The compan…

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