BioCentury
ARTICLE | Clinical News

Lutathera regulatory update

September 26, 2016 7:00 AM UTC

Advanced Accelerator said EMA converted the review period for an MAA for Lutathera to treat neuroendocrine tumors to a standard review from accelerated assessment. The change was based on EMA’s request for additional clarifications and to inspect 1 of Advanced Accelerator’s CROs. An NDA for Lutathera is under Priority Review in the U.S., with a Dec. 28 PDUFA date (see BioCentury, July 11). ...