The U.S. FDA seeks additional information relating to Advanced Accelerator Applications SA's new drug application for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors.
In a complete response letter, which follows a discipline review letter in November, the agency noted issues with the format, traceability, uniformity and completeness relating to datasets from certain clinical studies that are precluding its reviewers from performing the required independent analysis of the studies.
The letter requests subgroup analyses for gender, age and racial subgroups, as well as other stratification factors and important disease characteristics. A safety update on clinical and nonclinical studies, which is already in process, was also requested.
In addition, the FDA noted in the letter that any observations made during inspections of manufacturing facilities supporting the new drug application need to be resolved before the application's approval.
The agency did not request additional clinical studies, and there were no comments at this time on other sections of the new drug application submission.