FDA approves Curium's Bexlutry, challenging Novartis' Lutathera monopoly in GEP-NETs

The US FDA has approved Curium's Bexlutry, a radioligand therapy for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, challenging Novartis' Lutathera monopoly. The approval was granted via the 505(b)(2) pathway using bridging data and follows a patent litigation victory that clears the way for Bexlutry's market entry.

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