Lutathera Secures Priority Review

The FDA has granted priority review to Advanced Accelerator Applications’ Lutathera to treat gastroenteropancreatic neuroendocrine tumors.

The agency’s decision was based on a Phase 3 trial, pitting the treatment against a double dose of Octreotide LAR, in which Lutathera met its primary endpoint of statistically significant risk reduction at 79 percent.

The PDUFA date for Lutathera is Dec. 28.