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

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

The approval is primarily based on results from the single-arm, open-label ERASMUS study, in which the investigator-assessed objective response rate (ORR) with lutetium Lu 177 dotatate was 17% (95% CI, 13%-21%) among 360 patients with GEP-NETs who had long-term follow-up and baseline tumor assessments. Three patients had complete responses. Among 60 responders, the median duration of response was 35 months (95% CI, 17-38).²

“FDA approval of Bexlutry is a defining milestone for Curium as we expand our offering into oncology therapeutics. 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 NET patients access radioligand therapy with confidence,” Renaud Dehareng, executive officer of Curium, stated in a news release.¹

Safety of Lutetium Lu 177 Dotatate Injection

Safety data were available from 1214 patients enrolled in ERASMUS. Patients received lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) every 6 to 13 weeks, with or without octreotide.

A retrospective medical record review of 811 patients was conducted to assess serious adverse reactions. Among these patients, 81% received a cumulative lutetium Lu 177 dotatate dose of at least 22.2 GBq (600 mCi). With a median follow-up exceeding 4 years, serious adverse reactions included myelodysplastic syndrome in 2% of patients, acute leukemia in 1%, renal failure in 2%, hypotension in 1%, cardiac failure in 2%, myocardial infarction in 1%, and neuroendocrine hormonal crisis in 1%.

ERASMUS Trial Design and Treatment

ERASMUS was an international, single-institution, single-arm, open-label study involving patients with SSTR-positive tumors, including neuroendocrine tumors arising from different primary sites. Lutetium Lu 177 dotatate was initially administered through an expanded-access peptide receptor radionuclide therapy protocol at a single site in the Netherlands. A disease-specific protocol was subsequently developed approximately 8 years after study initiation and permitted retrospective collection of clinical data without a prespecified sample size or formal hypothesis-testing plan.

Overall, 1214 patients received lutetium Lu 177 dotatate in ERASMUS. Baseline tumor assessments were available for 578 patients, including 360 patients (62%) with GEP-NETs who had long-term follow-up. Within this GEP-NET group, 145 patients (40%) underwent prospective tumor assessment according to RECIST criteria. The FDA-labeled efficacy analysis required prospective response assessments for patients counted as responders.

The median age of patients in the efficacy population was 60 years (range, 30-85), 51% were male, and 71% had a baseline Karnofsky performance status of at least 90. Disease had progressed within 12 months before treatment in 51% of patients, while 7% had previously received chemotherapy. A concomitant somatostatin analog was administered to 52% of patients. The median cumulative lutetium Lu 177 dotatate dose was 29.6 GBq (800 mCi).

“As the only vertically integrated, lutetium-based NETs therapy manufacturer, Curium is uniquely positioned to support a reliable supply of Bexlutry 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,” Mike Patterson, Curium's North American chief executive officer, stated in the news release.²

REFERENCES

1. Curium. Curium announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs. Published September 14, 2026. https://tinyurl.com/4wck9wef

2. BEXLUTRY (lutetium Lu 177 dotatate injection) prescribing information. Curium Pharma. 2026. https://tinyurl.com/3762rt6d