Novartis: new subsidiary gets FDA approval
(CercleFinance.com) - Novartis' subsidiary Advanced Accelerator Applications has received approval from the US Food and Drug Administration (FDA) to launch a treatment for gastroenteropancreatic neuroendocrine tumors, the Swiss biopharmaceutical firm said.
More specifically, the FDA's decision on Lutathera concerns the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.
The approval was based on a Phase 3 study which demonstrated a 79% reduction in the risk of disease progression or death with Lutathera, which received orphan drug designation from the FDA.
Novartis recently completed its tender offer for Advanced Accelerator Applications, with the radiopharmaceutical company becoming an official unit of the group.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
More specifically, the FDA's decision on Lutathera concerns the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.
The approval was based on a Phase 3 study which demonstrated a 79% reduction in the risk of disease progression or death with Lutathera, which received orphan drug designation from the FDA.
Novartis recently completed its tender offer for Advanced Accelerator Applications, with the radiopharmaceutical company becoming an official unit of the group.
Copyright (c) 2018 CercleFinance.com. All rights reserved.