Advanced Accelerator reports FDA feedback for Lutathera
Last week, the FDA issued feedback to the NDA for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, 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.