FDA Approves Lutetium Lu 177 Dotatate Injection for SSTR+ GEP-NETs

The FDA has approved lutetium Lu 177 dotatate injection (Bexlutry) for the treatment of adult patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.¹

Lutetium Lu 177 dotatate injection is a radioligand therapy that delivers targeted radiation to GEP-NETs by binding to SSTRs that are commonly expressed on these tumors. This agent is a radioligand equivalent that was approved through the pathway targeting lutetium Lu 177 dotatate (Lutathera). The approval of lutetium Lu 177 dotatate injection was backed by data showing a similar biological and chemical profile to a previously approved radiopharmaceutical therapy.

“[The] FDA approval of [lutetium Lu 177 dotatate injection] is a defining milestone for Curium, as we expand our offering into oncology therapeutics,” Renaud Dehareng, the chief executive officer of Curium Group, stated in a news release. “With over 100 years of experience in nuclear medicine and a long-standing commitment to the NET community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly. For decades, Curium has earned trust in nuclear medicine through reliability, quality, and day-in, day-out delivery. We are applying that same discipline and commitment to help eligible [patients with] NETs access radioligand therapy with confidence.”

What was the design of the ERASMUS trial?

In the ERASMUS study, lutetium Lu 177 dotatate was originally provided under a general peptide receptor radionuclide therapy expanded-access program at a single site.² Subsequently, a protocol specific to lutetium Lu 177 dotatate was written after the study was initiated. Although this updated protocol did not specify a sample size or plan for testing hypotheses, it did allow for data to be collected retrospectively. Overall, 1214 patients were treated with lutetium Lu 177 dotatate injection as part of ERASMUS. In total, 578 patients had baseline tumor assessments, and 360 of those patients had GEP-NETs and long-term follow-up. Of those patients, 145 underwent prospective tumor evaluations per RECIST criteria.

Patients received lutetium Lu 177 dotatate injection at 7.4 GBq (200 mCi) every 6 to 13 weeks for a maximum of 4 doses; the agent was received concurrently with a recommended amino acid solution.

Investigator-assessed overall response rate (ORR) served as the primary end point.

What is the efficacy of lutetium Lu 177 dotatate injection in GEP-NETs?

In the efficacy-evaluable ERASMUS population, patients had a median age of 60 years (range, 30-85), 51% of patients were male, 71% of patients had a baseline Karnofsky performance status of at least 90, 51% of patients had progression of disease within 12 months of treatment, and 7% of patients had been treated with prior chemotherapy. In total, 52% of patients had received a concomitant somatostatin analog. Patients received lutetium Lu 177 dotatate injection at a median dose of 29.6 GBq (800 mCi).

The investigator-assessed ORR was 17% (95% CI, 13%-21%), including 3 complete responses, in an analysis that required responders to undergo prospective response assessments per RECIST criteria. Additionally, the median duration of response among responders (n = 60) was 35 months (95% CI, 17-38).

“As the only vertically integrated, lutetium-based NETs therapy manufacturer, Curium is uniquely positioned to support a reliable supply of [lutetium Lu 177 dotatate injection] and help sites of care prepare for radioligand therapy delivery at scale. Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer. Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.”

References

1. Curium announces FDA approval of Bexlutry lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs. News release. Curium. September 14, 2026. Accessed September 14, 2026. https://www.curiumpharma.com/2026/09/14/fda-approval-bexlutry/
2. Bexlutry. Prescribing information. Curium; September 2026. Accessed September 14, 2026. https://www.curiumpharma.com/wp-content/uploads/Bexlutry-PI.pdf