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Jump to Key Points The FDA has approved a generic version of the radioligand lutetium Lu 177 dotatate (Bexlutry, Curium) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including of the foregut, midgut, and hindgut.
The approval follows the agency's expansion of the label of the originator (Lutathera, Novartis) to children aged 12 years or older in April. The FDA said at the time that it was the first approval of a radioactive drug for children with SSTR-positive GEP-NETs.
Bexlutry was approved through the FDA's 505(b)(2) pathway as a radioligand equivalent, based on pharmacokinetic equivalence plus the ERASMUS trial in 360 adults with GEP-NETs. The overall response rate was 17% ORR with a median response duration of 35 months.
The most common grade 3 or 4 adverse events (affecting at least 4% of patients) were lymphopenia, gamma-glutamyl transferase elevations, vomiting, nausea, other liver enzyme increases, hyperglycemia, and hypokalemia. Warnings and precautions include myelosuppression, leukemia, and renal toxicity.
- FDA approved generic lutetium Lu 177 dotatate for adult SSTR+ GEP-NETs.
- Indications include foregut, midgut, and hindgut gastroenteropancreatic NETs.
- Approval via 505(b)(2) radioligand equivalence; PK equivalence + ERASMUS trial data.
- ERASMUS: ORR 17%; median response duration 35 months.
- Key risks: myelosuppression, leukemia, renal toxicity; dose 7.4 GBq q8wk ×4.
The recommended dose is 7.4 GBq every 8 weeks for four doses.
M. Alexander Otto is a physician assistant and award-winning journalist. He is also an MIT science journalism fellow. Email: aotto@medscape.net
