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诺华的Lutathera现在面临来自Cirium Bexlutry的仿制药竞争
2026-09-16 04:54
- The US FDA has approved Cirium's radioligand therapy Bexlutry (lutetium Lu 177 dotatate) for receptor-positive gastroenteropancreatic neuroendocrine tumors, the first such generic treatment approved for Novartis' (NVS) Lutathera.
- Approval was based on bridging data showing a similar biological and chemical profile to Lutathera.
- Like Lutathera, Bexlutry works by delivering targeted radiation to tumors by binding to somatostatin receptors frequently expressed on the tumors.
- Novartis reported $436M in Lutathera sales in the first half of 2026.
- The approval follows Cirium's August announcement it would acquire Lantheus Holdings (LNTH) in an $8B deal.
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