Advanced Accelerator Applications ($AAAP), which focuses on molecular nuclear medicine, will have its NDA assessed under a priority review for Lutathera--a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
The PDUFA target date is December 28, meaning an approval could come before the New Year, and in just 6 months under the U.S. regulator’s sped-up program for drugs that are believed to carry extra benefit to patients.
The Lutathera NDA is based on the results of the company’s pivotal Phase III study, NETTER-1, that compared Lutathera with a double dose of Novartis’ ($NVS) marketed Sandostatin (octreotide LAR) in patients with inoperable midgut NETs progressive under Novartis' treatment and overexpressing somatostatin receptors.
The study met its primary endpoint by showing Lutathera had a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death--versus a treatment with a double dose of Sandosatin LAR.
Novartis’ drug currently has a license for the treatment of patients with symptoms associated with functional gastroenteropancreatic endocrine tumors, as well as advanced neuroendocrine tumors of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded. AAA will hope to take some of that market share should it gain approval.
“We are encouraged that the FDA has granted Priority Review for Lutathera as a potential treatment for GEP-NETs,” said Stefano Buono, CEO of AAA. “We believe this action emphasizes the need to improve the lives of these patients.”
It’s been a good 12 months for the company, and just a few weeks ago the FDA approved its PET imaging diagnostic agent for neuroendocrine tumors. The nod came about 7 months after the French radiopharmaceutical diagnostics and biotech player raised $75 million in its IPO.
The company, which has a market cap of around $1 billion, was down by 0.8% early by midmorning, as European companies continue to struggle in the fallout from Brexit.
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