The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.
Lutathera consists of the somatostatin analog octreotide connected with the beta and gamma emitting radiopharmaceutical 177Lutetium (177Lu). The 2 components are connected using the chelator DOTA. Lutathera represents a new generation of PRRT, and has been tested in several single-arm studies. In these trials, the median PFS ranged from 1 to 3 years.
Strosberg JR, Wolin EM, Chasen B, et al. NETTER-1 phase III: Efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177Lu-DOTATATE. J Clin Oncol. 2016;34 (suppl; abstr 4005).
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