Home » Lutathera Secures Priority Review
Lutathera Secures Priority Review
July 1, 2016
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.
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