Advanced Accelerator Applications Receives US FDA Approval for Lutathera®

The approval represents one further step in the uphill battle against pancreatic cancer.

Barcelona, February 2, 2018 - We are pleased to share the recent approval by the FDA of Lutathera® for the treatment of gastroenteropancreatic tumors, including pancreatic neuroendocrine tumors (PNETs), that express somatostatin receptors. PNETs make up about 6 percent of all pancreatic cancer diagnoses. In the held Phase III clinical trial, Lutathera led to a 79 percent reduction in the risk of disease.

It is important to note that Lutathera® has not been approved, nor shown to be effective, in patients with the most common form of pancreatic cancer: adenocarcinoma.

For this reason, at Sagetis we continue to work on our lead candidate SAG-101, a coated oncolytic adenovirus for the treatment of adenocarcinoma.

We are glad to share news that bring light and hope to pancreatic cancer patients and we hope one day we will be able to bring such positive news as Lutathera® for the rest of pancreatic cancer patients.

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