Posted by Michael Wonder on 28 Nov 2016
Advanced Accelerator Applications reports feedback from the FDA for Lutathera, an investigational treatment for neuroendocrine tumours
28 November 2016 - Last week, the FDA issued feedback to the new drug application for Lutathera for the treatment of gastro-enteropancreatic neuroendocrine tumours in adults.
The FDA feedback identified issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets, which are precluding FDA reviewers from performing the required independent analysis of these clinical studies.
AAA will work closely with the FDA and the company’s Contract Research Organizations to resolve these issues and revise the data format to permit FDA review. AAA has concluded at this time that approval of Lutathera is unlikely to occur by the PDUFA date of December, 28, 2016.
The FDA comments were provided via a Discipline Review Letter, which is a letter sent to an applicant to convey early thoughts on possible deficiencies of an application. The letter refers to reviews of the Clinical, Statistical, and Clinical Pharmacology sections of the submission. The FDA noted that their feedback does not reflect a final decision, is preliminary and subject to change.
