However, advances in treatment have made it possible for more and more patients to be accurately diagnosed, seek the most appropriate treatment, and live with the disease. This can lead to delays in diagnosis or even misdiagnosis and inappropriate treatment. Symptoms often resemble those of other diseases, like sweating, diarrhea, abdominal pain, and GI bleeding. They have become the second most common cancer of the gastrointestinal tract. There are several types of NETs, but most occur throughout the gastrointestinal tract and lungs. Company Led Recall - NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) unlicensed medicine Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing. What are Neuroendocrine Tumors? Neuroendocrine Tumors (NETs) are a group of uncommon tumors. Gallium-68 dotatate (NETSPOT) is a new FDA-approved radiopharmaceutical test that makes Neuroendocrine Tumors visible on medical images for the purpose of accurate diagnosis and tracking. Novartis has agreed a 3.9bn deal to buy Advanced Accelerator Applications, a French company specialising in nuclear medicines used to treat tumours. This scan helps accurately locate and characterize tumors in adult patients with somatostatin-receptor positive Neuroendocrine Tumors (NETs). ![]() ITM had a generator for a long time under development that could compensate shortages for at least the next two years, but it still is not approved.” To conserve generator lifespan, distributors have resorted to self-imposed blackouts for NETSPOT doses, creating insufficient supplies and delays in procedures.What is NETSPOT (Gallium-68)? NETSPOT is the first Gallium-68 injection, a radioactive diagnostic agent for PET/CT imaging. IRE has now a generator with MA but due to internal reorganization, has not yet started growing capacity. “E&Z needs to build a new facility that itself needs approval from authorities, hence the date of mid-2019 to be ready. “The three companies able to sell generators or with generators under development underestimated the volume,” Richard Zimmermann, co-founder and partner of MEDraysintell and founder and senior consultant of nuclear medicine at Chrysalium Consulting SARL, told HCB News. Though planning to expand production with the construction of a new facility, E&Z will not be able to commence manufacturing there until mid-2019. Such needs have exacerbated production of Ge-68/Ga-68 generators, leading to waiting periods of between 14 and 18 months. The AAA reports that many often hit their elution limit before the end of one year. The solution is approved for 400 elutions or for use of up to one year, adding to demand with requests for replacements when such marks are reached. ![]() As of June 2018, approximately 500 imaging sites were requesting doses of NETSPOT for their neuroendocrine tumor patients.” Since its 2016 approval under E&Z, demand for the somatostatin receptor PET tracer has increased among those treating neuroendocrine tumors (NETs) in adult and pediatric patients, quickly replacing its market predecessor due to its patient-friendly regimen as an injection, reduction of imaging exams to approximately three hours, and its coverage by payors. Advanced Accelerator Applications (AAA) and has been expanding the network of pharmacies that distribute NETSPOT since its approval. “NETSPOT has experienced rapid adoption in the U.S. “NETSPOT is currently approved for use only with the GalliaPharm 68Ga generator from Eckert & Ziegler,” said the signatories in their letter. In a letter addressed to the FDA, the organization outlined the need for greater production, pointing to the demand for and benefits of GMP-grade germanium-68/gallium-68 generators, used to produce 68Ga for the subsequent production of NETSPOT, a kit for the preparation of gallium 68Ga dotatate injections. The Society of Nuclear Medicine and Molecular Imaging (SNMMI) has proposed three solutions for the shortage of generators used in the production of Gallium-68 throughout the U.S.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |