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In late October 2017, ''[[Reuters]]'' announced that [[Novartis]] would acquire the company for $3.9 billion, paying $41 per ordinary share and $82 per American depositary share representing a 47 percent premium.<ref>http://uk.reuters.com/article/uk-novartis-advanced-accelerator/novartis-to-buy-frances-advanced-accelerator-for-3-9-billion-idUKKBN1CZ0KM</ref> On January 22, 2018, Novartis AG (NYSE: NVS) announced the successful completion of the tender offer by its subsidiary, Novartis Groupe France S.A.<ref>[https://www.dddmag.com/news/2018/01/novartis-completes-tender-offer-advanced-accelerator-applications''Novartis Completes Tender Offer for Advanced Accelerator Applications Jan 2018]</ref>
==History==
It was approved by the FDA in January 2018 for GEP-NET.<ref>[https://www.healio.com/hematology-oncology/gastrointestinal-cancer/news/online/%7B5e89833e-97c3-4a91-a2c8-88231a517b78%7D/fda-approves-lutathera-for-gastroenteropancreatic-neuroendocrine-tumors ''FDA approves Lutathera for gastroenteropancreatic neuroendocrine tumors'' Jan 2018]</ref>
==== Approval ====
· Lutathera, also known as [[lutetium]] Lu 177 dotatate, is a target treatment drug for patients suffering from [[Neuroendocrine tumor|GEP-NETs]].<ref name=":0">{{Cite web|url=https://www.cancer.gov/news-events/cancer-currents-blog/2018/lutathera-fda-gastrointestinal-nets|title=FDA Approves New Treatment for Neuroendocrine Tumors|website=National Cancer Institute|language=en|access-date=2018-05-26}}</ref> Its approval for Advanced Accelerator Applications was announced on January 26, 2018 by the [[Food and Drug Administration|US Food and Drug Administration]].<ref name=":1">{{Cite web|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm|title=Press Announcements - FDA approves new treatment for certain digestive tract cancers|last=Commissioner|first=Office of the|website=www.fda.gov|language=en|access-date=2018-05-26}}</ref> Lutathera is most notable as the first FDA approved peptide receptor [[radionuclide]] therapy (PRRT) to combat GEP-NETs.<ref name=":2">{{Cite web|url=https://www.novartis.com/news/media-releases/advanced-accelerator-applications-receives-fda-approval-lutatherar-treatment-gastroenteropancreatic-neuroendocrine-tumors|title=Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors {{!}} Novartis|website=Novartis|language=en|access-date=2018-05-26}}</ref>
===== GEP-NETs =====
· [[Neuroendocrine tumor|GEP-NETs]] are rare groups of cancer that continue to proliferate, regardless of initial therapy treatments.<ref name=":0" /> They are present in areas affected by [[Pancreatic cancer|pancreatic]] or [[Gastrointestinal cancer|gastrointestinal cancers]]; specifically, the [[pancreas]], [[stomach]], [[intestines]], [[colon]] and [[rectum]].<ref name=":1" />
==== Use ====
· Lutathera is used to combat pancreatic and gastrointestinal cancers that do not respond well to common [[Chemotherapy|chemo]]<nowiki/>therapeutical treatments; namely for patients with [[somatostatin]] receptor-positive GEP-NETs.<ref name=":0" /><ref name=":1" /> These receptors are commonly found on tumors located in the [[foregut]], [[midgut]], and [[hindgut]].<ref name=":3">{{Cite web|url=https://lutathera.com/|title=For Patients - Lutathera|website=Lutathera|language=en-US|access-date=2018-05-26}}</ref>
==== Mechanism ====
· Lutathera is a radioactive drug comprisedconsisting of a [[tyrosine]]-containing somatostatin analog Tyr3-octreotate (TATE) attached to the [[Chelation|chelating]] agent tetraazacyclododecanetetra-[[Acetic acid (medical use)|acetic acid]] (DOTA).<ref name=":4">{{Cite web|url=https://www.cancer.gov/publications/dictionaries/cancer-drug|title=NCI Drug Dictionary|website=National Cancer Institute|language=en|access-date=2018-05-26}}</ref> Attached to the [[DOTA-TATE|dotatate]] is the radioactive marker Lu-177, a [[radioisotope]].<ref name=":0" /> The dotatate binds to the GEP-NET positive somatostatin receptor cells commonly present on [[neuroendocrine]] tumors.<ref name=":0" /><ref name=":4" /> After binding to the receptor, Lutathera enters the cell and uses its radioactive property to damage DNA.<ref name=":0" /> This mechanism effectively triggers [[apoptosis]] of cancerous tumor cells. As a result, studies found that 16% of patients being treated with Lutathera experienced either complete or partial tumor shrinkage.<ref name=":0" />
==== Studies ====
· FDA approval of Lutathera was ultimately supported by two clinical studies.<ref name=":1" /> NETTER-1, a Phase 3 study, was a randomized [[clinical trial]] which included patients with a severe form of somatostatin receptor-positive NETs.<ref name=":0" /><ref name=":2" /> The study compared Lutathera treatment with a standard dose of [[octreotide]]<nowiki/>d LAR against a high-dose of octreotide LAR.<ref name=":0" /> Researchers measured tumor growth after the course of the treatment, also known as [[progression-free survival]].<ref name=":1" /> The study concluded that patients who were treated with Lutathera lived substantially longer compared to those who only received the octreotide treatment.<ref name=":0" /> They experienced a 79% reduction in death and cancer progression.<ref name=":2" />
· The Netherlands study gathered several patients with somatostatin receptor-positive tumors, including patients with GEP-NETs.<ref name=":0" /> The study found that 16% of patients with GEP-NETs, who were treated with Lutathera, experienced complete or partial tumor shrinkage.<ref name=":0" /> As a result, a pre-planned interim overall survival analysis found that Lutathera treatment lead to a 48% reduction in risk of death.<ref name=":2" />
==== Common Grade 3-4 Adverse Reactions<ref name=":0" /><ref name=":1" /><ref name=":2" /><ref name=":3" /> ====
==== Advances ====
· Lutathera is a major technological advancement for the detection of tumors. [[Diagnostic imaging]] that relies on dotatates can now rely on Lutathera to locate somatostatin receptor-positive tumors by tagging them with its radioactive component.<ref name=":0" /> This tagging of tumors will allow them to become more visible during [[PET radiotracer|positron emission tomography]] (PET) scans.<ref name=":0" /> With LU-177 dotatates, more somatostatin receptor-positive GEP-NET patients can be identified for treatment of the disease.<ref name=":0" />
==Pipeline==
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