Advanced Accelerator Application’s Lutathera approval for GEP-NET could face FDA delays with long-term safety concerns, extended label in doubt – experts
Advanced Accelerator Applications’ (NASDAQ:AAAP) Lutathera (177Lu-DOTATATE) for gastroenteropancreatic neuroendocrine tumours (GEP-NET) could face further FDA approval delays if concerns about its safety profile persist due to its radiolabeled molecule, experts said. However, they were overall optimistic Lutathera would be eventually approved due to its encouraging efficacy data.
An analyst report shows approval in GEP-NET is anticipated. AAA received a Complete Response Letter (CRL) on December 2016 due concerns including format, traceability, uniformity and completeness relating to its Phase III NETTER-1 trial investigating Lutathera in midgut NET (NCT01578239) and Phase I/II datasets in multiple NETs.
Experts said this formatting and completeness CRL detail is not a major approval concern, with one investigator noting the Rockville, Maryland-based CRO Accelovance has since reformatted the application. An AAA spokesperson said many CROs were involved in the resubmission with the bulk of the work done by AAA. Accelovance did not respond to a request for comment.