![\"\"](\"https:\/\/www.citiusminds.com\/blog\/wp-content\/uploads\/2018\/12\/CitiusMinds_Lutathera_Cancer.png\")
(Source: <\/strong>Pixabay<\/strong><\/a>)<\/strong> <\/figcaption><\/figure><\/div>\n\n\n\n
Effected parts of body in Gastroenteropancreatic\nneuroendocrine tumor (GEP-NETs)<\/h3>\n\n\n\n
A Gastroenteropancreatic\nneuroendocrine tumor is formed in organs like pancreas and other gastrointestinal\ntract that includes stomach, small intestine, colon, rectum and appendix. The\nfigure below represents the distribution of GEP-NETs in various parts of the\nhuman body.<\/p>\n\n\n\n
![\"\"](\"https:\/\/www.citiusminds.com\/blog\/wp-content\/uploads\/2018\/12\/CitiusMinds_Lutathera_1.png\")
Figure. 1 (Source: <\/strong>Cancer Research and Treatment<\/strong><\/a>)<\/strong> <\/figcaption><\/figure><\/div>\n\n\n\n
Symptoms and Treatment options\nfor Gastroenteropancreatic neuroendocrine tumors<\/h3>\n\n\n\n
The Gastroenteropancreatic neuroendocrine\ntumor (GEP-NET) is a rare group of cancer which has very limited treatment\noptions and present many clinical challenges. At an early stage, there are no\nnoticeable symptoms but when it becomes malignant, it causes a constellation of\nsymptoms called carcinoid syndrome. These symptoms include:<\/p>\n\n\n\n
- Flushing (Redness of skin\nmostly face or cheeks)<\/li>
- Asthma or wheezing <\/li>
- Diarrhea<\/li>
- Congestive heart failure<\/li>
- Bronchospasm (Tightening of\nbronchi muscles)<\/li>
- Abdominal cramping<\/li>
- Peripheral edema (Accumulation\nof fluid in lower limbs)<\/li>
- Heart palpitations<\/li><\/ul>\n\n\n\n
Prior treatments\nincluded proper diagnosis and treatment often involved collaboration between\nspecialist in multiple disciplines using specific biochemical radiology and\nsurgical methods. The treatment of GEP-NETs is guided by the respectability of\nthe tumor, its location and extent of metastases and presence of other clinical\nsymptoms. The treatment of pancreatic NETs includes targeted agents like everolimus\nand sunitinib with an important role of chemotherapy. The expression of\nsomatostatin receptors in neuroendocrine tumors has facilitated its diagnosis\nand surgical treatment.<\/p>\n\n\n\n
How Radioactive drug Lutathera\nworks?<\/h3>\n\n\n\n
A radioactive\ndrug or radiopharmaceutical is a pharmaceutical agent that is used for\ntreatment as well as for diagnostic purposes. These radioactive agents consist\nof drug components and a radioactive element that emits gamma radiation. Recently,\nthe U.S Food Drug Administration approved LUTATHERA\n<\/strong>for the treatment of cancer affecting the pancreas and gastrointestinal\ntract.<\/p>\n\n\n\n
Lutathera is the\nfirst radioactive drug or radiopharmaceutical which has been approved for the\ntreatment of GEP-NETs. It is a type of somatostatin analog, also called lutetium\nLu 177-dotatate. It works by binding to the cell which has somatostatin\nreceptor which is generally present on the tumors. After it binds to the\nreceptor, it enters into the tumor cell and allows the radiation to cause\ndamage to the cell thereby removing the tumor.<\/p>\n\n\n\n
Dosage of Lutathera<\/h3>\n\n\n\n
Lutathera is administered\nby health providers directly by infusing into the blood, the process known as\nintravenous or IV infusion. This process takes nearly 30 minutes and is repeated\nonce every 8 weeks for a total of 4 doses.<\/p>\n\n\n\n
Clinical trials for Lutathera<\/h3>\n\n\n\n
The radioactive\ndrug or pharmaceutical Lutathera has been supported by two clinical studies:<\/p>\n\n\n\n
- The first clinical trial was conducted and studied on 229 patients who had advanced somatostatin receptor-positive GEP-NET. These patients received either octreotide alone or octreotide in combination with Lutathera. It was observed that patients who received Lutathera in combination with octreotide had longer progression-free survival as compared to those patients who received octreotide alone. The trial were conducted at different sites i.e. 41 sites in Belgium, Germany, France, Portugal, Italy, Spain, United Kingdom and the United States.<\/li>
- The figure below represents the male and female ratio that enrolled for this clinical trial to evaluate its safety and efficacy.<\/li><\/ul>\n\n\n\n
![\"\"](\"https:\/\/www.citiusminds.com\/blog\/wp-content\/uploads\/2018\/12\/CitiusMinds_Lutathera_2.png\")
Figure. 2<\/strong><\/figcaption><\/figure><\/div>\n\n\n\n- The next figure summarizes the percentage of patients enrolled in clinical trial 1 by race.<\/li><\/ul>\n\n\n\n
![\"\"](\"https:\/\/www.citiusminds.com\/blog\/wp-content\/uploads\/2018\/12\/CitiusMinds_Lutathera_3.png\")
Figure. 3 <\/strong><\/figcaption><\/figure><\/div>\n\n\n\n - The second clinical trial was conducted\non 1,214 patients with somatostatin receptor-positive tumors including GEP-NETs.\nThey received Lutathera at a single site in Netherlands. Complete or partial\ntumor shrinkage was reported in 16 percent of a subset of 360 patients with\nGEP-NETs who were evaluated for response by the FDA.<\/li><\/ul>\n\n\n\n
Side effects of Lutathera<\/h3>\n\n\n\n
The common side effects of Lutathera\ninclude:<\/p>\n\n\n\n
- Lymphopenia (Low levels of\nwhite blood cells)<\/li>
- High level of enzymes in\ncertain organs<\/li>
- Vomiting<\/li>
- Nausea<\/li>
- Hyperglycemia (High level of\nblood sugar)<\/li>
- Hypokalemia (Low level of\npotassium) <\/li><\/ul>\n\n\n\n
Serious side effects include:<\/p>\n\n\n\n
- Myelosuppression (Low level of\nblood sugar)<\/li>
- Development of blood or bone marrow cancer<\/li>
- Kidney damage<\/li>
- Hormonal imbalance<\/li>
- Can harm fetus during pregnancy<\/li><\/ul>\n\n\n\n
Patent information for\nLutathera<\/h3>\n\n\n\n
The FDA reviewed\nthe New drug application (NDA) for Lutathera to decide whether the drug was\nsafe and effective in its proposed use(s), whether the benefits of the drug\noutweighed the risks, whether the drug’s proposed labeling (package insert) was\nappropriate, and whether the methods used in manufacturing the drug and the\ncontrols used to maintain the drug’s quality are adequate to preserve the\ndrug’s identity, strength, quality, and purity. After the review, the FDA\ngranted the approval to sell or market Lutathera for the treatment of gastroenteropancreatic\nneuroendocrine tumors to Advanced Accelerator Applications USA, Inc. which is a\nsubsidiary of the Novartis group. As this drug was approved in January 2018,\ntherefore there are only 9 patent applications (as of October 17, 2018) filed\nby different companies\/institutes. The 2 most notable ones have been briefly\ndescribed below:-<\/p>\n\n\n\n
- US20180185524<\/a> titled \u201cMethod\nof Treatment of Neuroendocrine Tumors That Over-Express Somatostatin Receptors\u201d,\ngranted to Advanced Accelerator Applications, discloses a method for the\ntreatment of cancer that over express somatostatin receptors. This method\nincludes treating a patient using a combination of a Peptide Receptor\nRadionucliotide Therapy (PRRT) and an immune-oncology therapy, which produces a\ntherapeutic effect on said cancer. In this patent, PRRT is described as a\nradioactive drug that is Lutathera. <\/li><\/ul>\n\n\n\n
- US20180221499A1<\/a> titled \u201cSSTR-targeted conjugates and particles\nand formulations thereof\u201d, granted to Tarveda Therapeutics Inc., discloses a method\nfor reducing proliferation, increasing apoptosis or increasing cell cycle\narrest of cells by administering conjugate to the cells where conjugate is an\nactive agent which is coupled to somatostatin receptor targeting moiety. The active\nagent, as described in this patent is mertansine and an additional active agent\ni.e. Lutathera can also be used.<\/li><\/ul>\n\n\n\n
Various applications for a radioactive\ndrug (Lutathera) has been filed and approved worldwide.<\/h3>\n\n\n\n
\n Application Number<\/strong>\n <\/td> \n Publication Date<\/strong>\n <\/td> \n Drug Substance Claimed<\/strong>\n <\/td> \n Application Use<\/strong>\n <\/td> \n Applicant<\/strong>\n <\/td><\/tr> \n US20160271279A1<\/a><\/strong>\n <\/td> \n September\n 22, 2016\n <\/td> \n Yes\n <\/td> \n Pharmaceutical\n Composition\n <\/td> \n North-West University\n <\/td><\/tr> \n US20170087260A1<\/a><\/strong>\n <\/td> \n March\n 30, 2017\n <\/td> \n –\n <\/td> \n Production\n of radiopharmaceuticals\n <\/td> \n Scherrer Institute Paul\n <\/td><\/tr> \n WO2017127710A1<\/a><\/strong>\n <\/td> \n July\n 27, 2017\n <\/td> \n –\n <\/td> \n Treatment\n of Neuroendocrine Tumors\n <\/td> \n Chiasma Inc.\n <\/td><\/tr> \n WO2017210246A2<\/a><\/strong>\n <\/td> \n December\n 07, 2017\n <\/td> \n Yes\n <\/td> \n Pharmaceutical\n composition\n <\/td> \n Tarveda\n Therapeutics Inc.\n <\/td><\/tr> \n SG11201710255A1<\/a><\/strong>\n <\/td> \n January\n 01, 2018\n <\/td> \n –\n <\/td> \n Treatment\n of Neuroendocrine Tumors\n <\/td> \n Advanced\n Accelerator Applications\n <\/td><\/tr> \n WO2018081521A1<\/a><\/strong>\n <\/td> \n May\n 03, 2018\n <\/td> \n No\n <\/td> \n Pharmaceutical\n composition\n <\/td> \n Tarveda\n Therapeutics Inc.\n <\/td><\/tr> \n US20180185524A1<\/a><\/strong>\n <\/td> \n July\n 05, 2018\n <\/td> \n –\n <\/td> \n Treatment\n of Neuroendocrine Tumors\n <\/td> \n Advanced\n Accelerator Applications\n <\/td><\/tr> \n EP3378068A1<\/a><\/strong>\n <\/td> \n September\n 26, 2018\n <\/td> \n –\n <\/td> \n Administering\n Radio-pharmaceutical drug\n <\/td> \n Assist Publique Hopitaux De Paris\n <\/td><\/tr> \n US20180221499A1<\/a><\/strong>\n <\/td> \n August\n 09, 2018\n <\/td> \n Yes\n <\/td> \n Pharmaceutical\n composition\n <\/td> \n Tarveda\n Therapeutics Inc.\n <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n The chart below (Figure.\n4) shows the patent application profile of Lutathera for the several assignees.<\/p>\n\n\n\n
![\"\"](\"https:\/\/www.citiusminds.com\/blog\/wp-content\/uploads\/2018\/12\/CitiusMinds_Lutathera_4.png\")
Figure. 4<\/strong><\/figcaption><\/figure><\/div>\n\n\n\n Conclusion<\/h3>\n\n\n\n
\n\nThe Gastroenteropancreatic neuroendocrine tumor\n(GEP-NET) being a silent disease at its initial stage makes it difficult to\ndiagnose until it becomes a malignant tumor. Earlier patients with GEP-NET had very\nlimited treatment options as they would get to know about it only after the\ntumor would become malignant and start invading other parts of the body. The\nFDA has recently approved Lutathera (Lu 177-dotatate) which proved to be very\nadvantageous for the treatment of GEP-NETs in several clinical trials.\nAccording to clinical trials performed on various patients, besides treatment\nof the cancer, the Lutathera drug is also helpful in the diagnosis of the\ndisease before it invades other parts of the organ. This is just one small step\ntowards our long running fight against cancer. Several companies have been\nresearching to find drugs or compounds that may be helpful for the treatment\nand cure of cancer. Only due to these efforts, the human race has now reached a\nstage where we can now defeat Cancer and it is no more a fatal disease. We hope\nto be able to totally eradicate it from our planet, but if that is even\npossible, only time will tell.\n\n\n\n<\/p>\n","protected":false},"excerpt":{"rendered":"
There are over 200 different types of Cancer, the most common being skin cancer, breast cancer, ovarian cancer, prostate cancer and lymphoma. Symptoms of cancer and its signs depend on the type of cancer which can vary from patient to patient. The treatment protocol for cancer also depends on the type and stage of cancer […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[19,18],"tags":[97,30,44,224,511,40],"class_list":["post-3203","post","type-post","status-publish","format-standard","hentry","category-latest-from-the-greatest","category-technicalanalysis","tag-iot","tag-patent","tag-patent-application","tag-patent-applications","tag-treatment","tag-uspto"],"_links":{"self":[{"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/posts\/3203","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/comments?post=3203"}],"version-history":[{"count":0,"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/posts\/3203\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/media?parent=3203"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/categories?post=3203"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.citiusminds.com\/blog\/wp-json\/wp\/v2\/tags?post=3203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
- US20180221499A1<\/a> titled \u201cSSTR-targeted conjugates and particles\nand formulations thereof\u201d, granted to Tarveda Therapeutics Inc., discloses a method\nfor reducing proliferation, increasing apoptosis or increasing cell cycle\narrest of cells by administering conjugate to the cells where conjugate is an\nactive agent which is coupled to somatostatin receptor targeting moiety. The active\nagent, as described in this patent is mertansine and an additional active agent\ni.e. Lutathera can also be used.<\/li><\/ul>\n\n\n\n
- US20180185524<\/a> titled \u201cMethod\nof Treatment of Neuroendocrine Tumors That Over-Express Somatostatin Receptors\u201d,\ngranted to Advanced Accelerator Applications, discloses a method for the\ntreatment of cancer that over express somatostatin receptors. This method\nincludes treating a patient using a combination of a Peptide Receptor\nRadionucliotide Therapy (PRRT) and an immune-oncology therapy, which produces a\ntherapeutic effect on said cancer. In this patent, PRRT is described as a\nradioactive drug that is Lutathera. <\/li><\/ul>\n\n\n\n
- The second clinical trial was conducted\non 1,214 patients with somatostatin receptor-positive tumors including GEP-NETs.\nThey received Lutathera at a single site in Netherlands. Complete or partial\ntumor shrinkage was reported in 16 percent of a subset of 360 patients with\nGEP-NETs who were evaluated for response by the FDA.<\/li><\/ul>\n\n\n\n
- The next figure summarizes the percentage of patients enrolled in clinical trial 1 by race.<\/li><\/ul>\n\n\n\n