AAA today announced that the resubmission of the New Drug Application (NDA) for investigational drug lutetium Lu 177 dotatate* (Lutathera®) to the US Food and Drug Administration (FDA) was completed. AAA resubmitted the NDA following receipt of a complete response letter (CRL) from the FDA in December 2016, in which the Agency cited issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets, which precluded FDA reviewers from performing the required independent analysis of these clinical studies.
The company also announced that the FDA allowed an amendment to the protocol for the US Expanded Access Program (EAP) for lutetium Lu 177 dotatate (Lutathera®) to permit enrollment of patients with metastasized or locally advanced, inoperable neuroendocrine tumors (NETs) arising at all sites (including foregut, midgut and hindgut), and that have progressive disease during or after treatment with somatostatin analogues. In addition, the amendment includes the use of a 2.5% lysine/arginine amino acid solution as an additional option for renal protection.