Novartis proclaimed FDA approval of NDA for Lutathera

Advanced Accelerator Applications which is a subsidiary of Novartis Groupe S.A sought U.S Food and Drug administration’s assent for its New drug application (NDA) for  Lutathera (lutetium Lu 177 dotatate) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) encompassing foregut, midgut, and hindgut neuroendocrine tumors, in adults. NETs are rare tumors originating in the neuroendocrine cells of numerous organs, including the gastrointestinal tract, pancreas and lung

FDA extended orphan drug designation to Lutathera is FDA– approved Peptide Receptor Radionuclide Therapy (PRRT), a form of treatment comprising of a targeting molecule that carries a radioactive component. Phase 3 study marked a 79% reduction in the risk of disease progression or death.

Susanne Schaffert, Ph.D., Chairperson and President, Advanced Accelerator Applications said “For 30 years, Novartis has supported the NET community with the development of therapeutics in NET and carcinoid syndrome. I cannot think of a better way to commemorate the joining of two organizations and our future together as we advance new nuclear medicine therapeutics in NET as well as across other tumor types.”

The estimated incidence, or rate of new cases, of NETs in the United States is approximately 6.98/100,000 per year, while the estimated prevalence for 2014, based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database, was 171,321.

Lutathera enumerates certain safety warnings and precautions like Radiation Exposure, Myelosuppression, Secondary Myelodysplastic Syndrome and Leukemia,Renal Toxicity,Hepatotoxicity having several drug interactions and adverse events attached to it.

Image Source: Novartis