The Netherlands study gathered several patients with somatostatin receptor-positive tumors, including patients with GEP-NETs. They experienced a 79% reduction in death and cancer progression. The study concluded that patients who were treated with Lutathera lived substantially longer compared to those who only received the octreotide treatment. Researchers measured tumor growth after the course of the treatment, also known as progression-free survival. The study compared Lutathera treatment with a standard dose of octreotided LAR against a high-dose of octreotide LAR.
#Aaa netspot trial
NETTER-1, a Phase 3 study, was a randomized clinical trial which included patients with a severe form of somatostatin receptor-positive NETs. Studies įDA approval of Lutathera was ultimately supported by two clinical studies. As a result, studies found that 16% of patients being treated with Lutathera experienced either complete or partial tumor shrinkage. This mechanism effectively triggers apoptosis of cancerous tumor cells. After binding to the receptor, Lutathera enters the cell and uses its radioactive property to damage DNA. The dotatate binds to the GEP-NET positive somatostatin receptor cells commonly present on neuroendocrine tumors. Attached to the dotatate is the radioactive marker Lu-177, a radioisotope. Lutathera is a radioactive drug consisting of a tyrosine-containing somatostatin analog Tyr3-octreotate (TATE) attached to the chelating agent tetraazacyclododecanetetra- acetic acid (DOTA). These receptors are commonly found on tumors located in the foregut, midgut, and hindgut.
Lutathera is used to combat pancreatic and gastrointestinal cancers that do not respond well to common chemotherapeutical treatments namely for patients with somatostatin receptor-positive GEP-NETs. They are present in areas affected by pancreatic or gastrointestinal cancers specifically, the pancreas, stomach, intestines, colon and rectum. GEP-NETs are rare groups of cancer that continue to proliferate, regardless of initial therapy treatments. Lutathera is most notable as the first FDA approved peptide receptor radionuclide therapy (PRRT) to combat GEP-NETs. Its approval for Advanced Accelerator Applications was announced on January 26, 2018, by the US Food and Drug Administration. Lutathera, also known as lutetium Lu 177 dotatate, is a target treatment drug for patients with GEP-NETs. It was approved by the FDA in January 2018 for GEP-NET. It selectively targets over-expressed somatostatin receptors while also giving off gamma emissions to allow physicians to visualize where in the body both the drug and the tumor are. The company's lead product is LUTATHERA, a Lutetium Lu 177 dotatate labeled somatostatin analogue peptide, a theragnostic cancer product being developed to treat certain gastro-entero pancreatic neuroendocrine tumors ( GEP-NETs). See also: Peptide receptor radionuclide therapy The group's portfolio of radiopharmaceuticals includes radioactive agents for positron emission tomography ( PET) imaging as well as single-photon emission computed tomography ( SPECT) diagnostic products. Products ĪAA has a portfolio of diagnostic and therapeutic applications and products in the fields of Molecular Imaging and Therapy. ĪAA currently has a total of 31 sites in 12 countries, including: 19 production facilities in 8 countries (in Europe and the U.S.) that manufacture targeted radioligand therapies and precision imaging radioligands, and 6 sites with R&D activity.
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