Home » Lutathera Secures Priority Review
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.
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