Novartis has announced that it has received U.S. FDA approval of its new drug application for Lutathera for the treatment of pancreatic neuroendocrine tumors (NETs).
NETs are rare tumors originating in the neuroendocrine cells of numerous organs, including the gastrointestinal tract, pancreas and lung.
The Pancreatic Cancer Action Network has called this an “unprecedented drug approval” because Lutathera is a first-in-class drug and the first available FDA-approved Peptide Receptor Radionuclide Therapy. According to PanCAN, “While the FDA has already approved similar drugs for neuroendocrine tumor patients in the United States, Lutathera takes treatment a step further by selectively delivering radiotherapy to the PNETs using a somatostatin analog."
Novartis purchased Advanced Accelerator Applications — a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines — along with Lutathera, late last year in a $3.9 billion deal.
Read the press release