CRL for Advanced Accelerator's Lutathera

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) said FDA issued a complete response letter for Lutathera (177-Lu-Dotatate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The company said in late November that FDA issued a "discipline review" letter, and did not expect the agency to approve Lutathera's NDA by its Dec. 28 PDUFA date.

On Wednesday, Advanced Accelerator said the CRL raises issues with existing clinical data sets, requests subgroup analyses and a safety update, and says the company must resolve manufacturing concerns. The company said FDA did not request additional clinical studies...