FDA clears Curium's generic lutetium Lu 177 dotatate for neuroendocrine tumors

The FDA has approved Bexlutry (lutetium Lu 177 dotatate), a generic radioligand therapy targeting somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, as an alternative to Novartis’ Lutathera.

• Approval granted via FDA’s 505(b)(2) pathway based on bridging data showing a similar biological and chemical profile to Lutathera.
• The FDA’s decision followed a June court ruling that cleared Curium of patent-infringement claims from Novartis.
• Curium recently agreed to acquire Lantheus, which also had tentative FDA approval for a competing generic, for up to $8 billion.

Automated summary

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