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The NDA seeking approval of 177Lu-edotreotide for the treatment of patients with GEP-NETs has been accepted by the FDA.
The FDA has accepted a new drug application (NDA) seeking the approval of 177Lu-edotreotide (ITM-11) for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).1 The Prescription Drug User Fee Act target action date has been set for August 28, 2026.
The NDA is supported by data from the phase 3 COMPETE trial (NCT03049189). Findings from COMPETE presented during the 2025 ESMO Congress demonstrated that patients who received 177Lu-edotreotide (n = 207) achieved a median progression-free survival (PFS) per blinded independent central review (BICR) of 23.9 months (95% CI, 18.7-30.0) compared with 14.1 months (95% CI, 9.2-20.9) among patients who received everolimus (Afinitor; n = 102; HR, 0.67; 95% CI, 0.48-0.95; P = .022).2 The overall response rate (ORR) per BICR was 21.9% in the investigational arm vs 4.2% in the control arm (P < .0001). These findings met the primary and key secondary end points of the trial.
“The FDA’s acceptance of our NDA is an important regulatory milestone in advancing this new radiopharmaceutical treatment option for patients with GEP-NETs,” Celine Wilke, MD, chief medical officer of ITM, stated in a news release.1 “In the phase 3 COMPETE trial, 177Lu-edotreotide demonstrated extended PFS, a straightforward dosing regimen, and a favorable safety profile, supporting its potential to improve the current treatment paradigm. We look forward to working closely with the FDA toward potential approval.”
177Lu-edotreotide previously received fast track designation from the FDA for the treatment of patients with GEP-NETs in October 2022.3
COMPETE was a prospective, controlled, open-label, multicenter study that enrolled adult patients with grade 1 or 2 unresectable or metastatic, progressive somatostatin receptor–positive disease.2 Patients also needed to be treatment naive or have experienced disease progression following first-line therapy, and a glomerular filtration rate of at least 60 mL/min/1.73 m2 was also required.
Patients were randomly assigned 2:1 to receive 177Lu-edotreotide or oral everolimus at 10 mg daily. Those in the 177Lu-edotreotide arm received the agent intravenously at 7.5 GBq ± 0.07 GBq for 4 cycles; each cycle occurred every 3 months starting at month 0.
The primary end point was PFS per RECIST 1.1 criteria by BICR. ORR represented the trial’s key secondary end point. Other secondary end points included overall survival, disease control rate, duration of disease control, health-related quality of life, and safety and tolerability.
The median PFS per local assessment in the investigational and control arms was 24.1 months (95% CI, 21.1-26.7) and 17.6 months (95% CI, 12.2-21.0) for 177Lu-edotreotide and everolimus, respectively (HR, 0.66; 95% CI, 0.48-0.91; P = .010). The ORRs per local assessment were 30.5% and 8.4%, respectively (P < .0001).
In terms of safety, 177Lu-edotreotide was found to be well tolerated. Patients in the safety population of the investigational arm (n = 217) experienced any-grade treatment-emergent adverse effects (TEAEs) at a rate of 82.0% compared with 97.0% in the control arm (n = 99). Patients in both arms experienced at least 1 TEAE related to study drug discontinuation (1.8% vs 15.2%) and dose modification or discontinuation (3.7% vs 52.5%). Two patients in the investigational arm delayed study drug administration due to toxicity.
“This [NDA] milestone reflects more than 20 years of leadership and dedication to advancing the radiopharmaceutical field, built on our global isotope manufacturing, clinical expertise, and pipeline of targeted therapeutics and diagnostics,” Andrew Cavey, MD, chief executive officer of ITM, added in the news release.1 “Above all, we are driven by a single focus: making a real difference for people living with hard-to-treat cancers.”
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