With this approval, AAA’s first theragnostic pairing, based on radiolabeling the same targeting molecule with either lutetium 177 or gallium 68, respectively for therapeutic or diagnostic 2 purposes is complete. Stefano Buono, Advisor and former Chief Executive Officer of Advanced Accelerator Applications, stated, “The approval of LUTATHERA® is the culmination of years of hard work and partnership with numerous physicians and patients. We believe nuclear medicine has the potential to offer many benefits to cancer patients and will use this approval as a foundation for the development of additional targeted cancer treatments utilizing radiolabeled ligands.” “As the first PRRT ever approved in the US, LUTATHERA® is introducing a major advancement in the treatment paradigm for these patients that we hope will improve many lives. “The approval of LUTATHERA® marks an important achievement and innovation for the NET community,” said Susanne Schaffert, PhD, Chairperson and President of Advanced Accelerator Applications. Patients with well- and moderately-differentiated tumors and distant metastases have a 5-year survival probability of 35%. 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 171,321.1 Patient survival with advanced GEPNETs depends on stage and histology. Some patients develop symptoms arising from the excessive production of hormones by neuroendocrine tumor cells, while others remain clinically silent for years. NETs are rare tumors originating in the neuroendocrine cells of numerous organs, including the gastrointestinal tract, pancreas and lung. LUTATHERA®, which received orphan drug designation from the FDA, is a first-in-class drug and the first available FDA-approved Peptide Receptor Radionuclide Therapy (PRRT), a form of targeted treatment comprising a targeting molecule that carries a radioactive component. (NASDAQ:AAAP) (AAA or the Company), a Novartis company and leader in nuclear medicine theragnostics, today announced that it has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for LUTATHERA® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Arrangements will be been made by Advanced Accelerator Applications to resupply hospital sites with unaffected products.Advanced Accelerator Applications S.A. The remaining stock of the above batches should be quarantined and returned to the company directly.
#Netspot drug full#
This recall is being issued as a company-led medicines recall, as this product is only supplied to several hospitals/customers and the manufacturer has full traceability. Brief description of the problemĪn Out-of-Specification (OOS) result was obtained during a stability study.
#Netspot drug update#
**Following correction by Advanced Accelerator Applications, an update was made on 22 March 2022 to reflect correction of the expiry date.
NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) Batch NumberĪctive Pharmaceutical Ingredient: 40mcg dotatate Advanced Accelerator Applications Product description
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