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News
The FDA has approved Bexlutry (lutetium Lu 177 dotatate injection) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It's the first FDA-approved radioligand equivalent to Lutathera, cleared via the 505(b)(2) pathway. The therapy works by binding to overexpressed receptors on tumor cells and destroying them with targeted radiation from within.
The FDA has approved Bexlutry™ (lutetium Lu 177 dotatate injection) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) — including foregut, midgut, and hindgut variants. Developed by Curium, Bexlutry is a radiolabeled somatostatin analog that homes in on cancer cells by binding to somatostatin receptors (primarily subtype 2), which are overexpressed on GEP-NETs. Once bound, the compound is internalized and delivers targeted beta radiation to destroy tumor cells from the inside out.
Bexlutry earned its approval through the FDA's 505(b)(2) pathway, making it the first approved radioligand equivalent to Lutathera® — an already-established therapy for the same indication. This pathway lets manufacturers leverage existing clinical evidence plus bridging data to show a similar biological and chemical profile to the reference product, streamlining the path to approval.
By the Numbers
Why it matters: Bexlutry's approval expands access to targeted radioligand therapy for GEP-NET patients and introduces competition in a space previously dominated by a single product. With Curium's vertically integrated manufacturing, the company is positioned to support reliable, scalable supply — a critical factor for a therapy that requires specialized delivery infrastructure.
