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The FDA has rejected approval of ¹⁷⁷Lu-edotreotide (ITM-11), a radioligand for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), due to chemistry, manufacturing, and control issues, according to maker Isotope Technologies Munich (ITM).
The agency also cited "third-party commercial facility inspection-related items" in a complete response letter, ITM said in a statement. The FDA did not identify "clinical safety or efficacy issues" or ask for "additional clinical or nonclinical data."
The company said it's reviewing the agency's feedback, assessing the next steps with relevant external parties, and plans to resubmit its new drug application. It "remains confident in the potential of ITM-11."
The COMPETE trial compared ITM-11 with everolimus in 309 patients with inoperable, progressive grade 1 or 2 GEP-NETs. Median progression-free survival, the primary endpoint, was 14.1 months with everolimus vs 23.9 months with the radioligand.
M. Alexander Otto is a physician assistant and award-winning journalist. He is also an MIT science journalism fellow. Email: aotto@medscape.net
