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Imatinib
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==Medical uses== Imatinib is used to treat [[chronic myelogenous leukemia]] (CML), [[gastrointestinal stromal tumor]]s (GISTs) and a number of other [[malignancy|malignancies]]. In 2006 the FDA expanded approved use to include [[dermatofibrosarcoma protuberans]] (DFSP), [[Myelodysplastic syndrome|myelodysplastic]]/myeloproliferative diseases (MDS/MPD), and aggressive systemic [[mastocytosis]] (ASM).<ref name="cancernetwork.com">{{Cite journal |date=1 November 2006|title=Gleevec Gains Simultaneous FDA Approval for Five Rare, Life-Threatening Disorders|url=https://www.cancernetwork.com/gastrointestinal-cancer/gleevec-gains-simultaneous-fda-approval-five-rare-life-threatening-disorders|access-date=10 June 2020 |website=Cancer Network |series=Oncology NEWS International Vol 15 No 11 |volume=15 |issue=11 |language=en |archive-date=10 June 2020 |archive-url=https://web.archive.org/web/20200610130239/https://www.cancernetwork.com/gastrointestinal-cancer/gleevec-gains-simultaneous-fda-approval-five-rare-life-threatening-disorders |url-status=dead}}</ref> Imatinib is considered to be a very effective treatment for CML, and has been shown to improve outcomes for people with this type of leukemia. It can also be used to treat some types of ALL, but is not considered a standard of care for ALL. In many cases, Imatinib can induce a complete cytogenetic response (CCyR) and major molecular response (MMR) and many patients can have a long-term remission. It is also used to maintain remission in chronic phase CML patients. While Imatinib is a very effective treatment for CML and some types of ALL, it is not a cure for leukemia. Instead, it is a 'chronic therapy' that helps to control the disease and prevent it from progressing. Some patients may need to continue taking Imatinib for an extended period of time to maintain remission, and some patients may eventually require additional treatment options. ===Chronic myelogenous leukemia=== The U.S. [[Food and Drug Administration]] (FDA) has approved imatinib as first-line treatment for [[Philadelphia chromosome]]-positive CML, both in adults and children. The drug is approved in multiple contexts of Philadelphia chromosome-positive CML, including after stem cell transplant, in blast crisis, and newly diagnosed.<ref name="FDA">{{cite web |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf |title=FDA Highlights and Prescribing Information for Gleevec(imatinib mesylate) |url-status=live |archive-url=https://web.archive.org/web/20140913120652/http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf |archive-date=13 September 2014 }}</ref> Due in part to the development of imatinib and related drugs, the five-year survival rate for people with chronic myeloid leukemia increased from 31% in 1993, to 59% in 2009,<ref>{{cite web |url=http://www.cancer.net/cancer-types/leukemia-chronic-myeloid-cml/statistics |title=Leukemia – Chronic Myeloid – CML: Statistics | Cancer.Net |url-status=live |archive-url=https://web.archive.org/web/20141112155938/http://www.cancer.net/cancer-types/leukemia-chronic-myeloid-cml/statistics |archive-date=12 November 2014 |date=26 June 2012}}</ref> to 70% in 2016.<ref>{{cite web |title=Cancer Stat Facts: Leukemia – Chronic Myeloid Leukemia (CML) |url=https://seer.cancer.gov/statfacts/html/cmyl.html |website=Cancer.gov |access-date=17 April 2020 |archive-date=1 February 2020 |archive-url=https://web.archive.org/web/20200201203304/https://seer.cancer.gov/statfacts/html/cmyl.html |url-status=live }}</ref> By 2023, the five year survival rate for people with chronic myeloid leukemia had risen to 90%.<ref>{{cite web |url=https://cancer.ca/en/cancer-information/cancer-types/chronic-myeloid-leukemia-cml/prognosis-and-survival/survival-statistics#:~:text=The%205%2Dyear%20relative%20survival,sex%20in%20the%20general%20population | title=Survival statistics for chronic myeloid leukemia | date=September 2022 | access-date=13 December 2023 | archive-date=13 December 2023 | archive-url=https://web.archive.org/web/20231213065443/https://cancer.ca/en/cancer-information/cancer-types/chronic-myeloid-leukemia-cml/prognosis-and-survival/survival-statistics#:~:text=The%205%2Dyear%20relative%20survival,sex%20in%20the%20general%20population | url-status=live }}</ref> Starting from 2011, it became clear that CML patients who continue to respond to imatinib have the same or almost the same life expectancy as the general population.<ref>{{cite journal |vauthors=Gambacorti-Passerini C, Antolini L, Mahon FX, et al. |title=Multicenter independent assessment of outcomes in chronic myeloid leukemia patients treated with imatinib |journal=J. Natl. Cancer Inst. |volume=103 |issue=7 |pages=553–561|date=March 2011 |doi=10.1093/jnci/djr060 |pmid=21422402 |doi-access=free}}</ref> ===Gastrointestinal stromal tumors=== The FDA first granted approval for advanced GIST patients in 2002. On 1 February 2012, imatinib was approved for use after the surgical removal of [[CD117|KIT]]-positive tumors to help prevent recurrence.<ref name="onclive">{{cite web |title=Prolonged Use of Imatinib in GIST Patients Leads to New FDA Approval |date=February 2012 |url=http://www.onclive.com/web-exclusives/Prolonged-Use-of-Imatinib-in-GIST-Patients-Leads-to-New-FDA-Approval |url-status=live |archive-url=https://web.archive.org/web/20120204082247/http://www.onclive.com/web-exclusives/Prolonged-Use-of-Imatinib-in-GIST-Patients-Leads-to-New-FDA-Approval |archive-date=4 February 2012 }}</ref> The drug is also approved in unresectable KIT-positive GISTs.<ref name="FDA" /> ===Dermatofibrosarcoma protuberans (DFSP)=== The FDA granted approval for the treatment of [[dermatofibrosarcoma protuberans]] (DFSP) patients in 2006.<ref name="cancernetwork.com"/> Specifically adult patients with unresectable, recurrent and/or [[Metastasis|metastatic]] dermatofibrosarcoma protuberans (DFSP). Prior to approval DFSP was considered unresponsive to [[chemotherapy]] treatments. ===Other=== The FDA has approved imatinib for use in adults with relapsed or refractory Philadelphia chromosome-positive [[acute lymphoblastic leukemia]] (Ph+ ALL), [[myelodysplastic]]/[[myeloproliferative]] diseases associated with [[PDGFR|platelet-derived growth factor receptor]] gene rearrangements, aggressive systemic [[mastocytosis]] without or an unknown D816V c-KIT mutation, [[hypereosinophilic syndrome]] and/or [[chronic eosinophilic leukemia]] who have the [[FIP1L1#FIP1L1-PDGFRA|FIP1L1-PDGFRα]] fusion kinase (CHIC2 allele deletion) or FIP1L1-PDGFRα fusion kinase negative or unknown, unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.<ref name="FDA" /> On 25 January 2013, Gleevec was approved for use in children with Ph+ ALL.<ref>{{cite web|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336868.htm|title=FDA approves Gleevec for children with acute lymphoblastic leukemia|date=25 January 2013|work=FDA News Release|publisher=US Food and Drug Administration|access-date=3 April 2013|url-status=dead|archive-url=https://web.archive.org/web/20130310094645/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336868.htm|archive-date=10 March 2013}}</ref> For treatment of progressive [[Neurofibroma#Plexiform neurofibroma|plexiform neurofibromas]] associated with [[neurofibromatosis type I]], early research has shown potential for using the c-KIT tyrosine kinase blocking properties of imatinib.<ref name="pmid18984156">{{cite journal |vauthors=Yang FC, Ingram DA, Chen S, Zhu Y, Yuan J, Li X, Yang X, Knowles S, Horn W, Li Y, Zhang S, Yang Y, Vakili ST, Yu M, Burns D, Robertson K, Hutchins G, Parada LF, Clapp DW | title = Nf1-dependent tumors require a microenvironment containing Nf1+/--and c-kit-dependent bone marrow | journal = Cell | volume = 135 | issue = 3 | pages = 437–48 |date=October 2008 | pmid = 18984156 | pmc = 2788814 | doi = 10.1016/j.cell.2008.08.041 |doi-access=free }} *{{lay source |template = cite press release|url=https://www.sciencedaily.com/releases/2008/10/081030123837.htm|title = Gleevec Holds Potential As First Drug To Successfully Treat Neurofibromatosis, Scientists Report|date = 31 October 2008 |website = ScienceDaily }}</ref><ref>{{cite web|url=http://www.nfcure.org/newnf1trial/gleevecnf1trial.html|title=Gleevec NF1 Trial|publisher=Nfcure.org|access-date=3 April 2013|url-status=dead|archive-url=https://web.archive.org/web/20120420015449/http://nfcure.org/newnf1trial/gleevecnf1trial.html|archive-date=20 April 2012}}</ref><ref>{{cite web |url=http://www.gistsupport.org/about-gist/gist-in-neurofibromatosis-1.php |title=GIST in Neurofibromatosis 1 |publisher=Gistsupport.org |date=14 May 2010 |access-date=3 April 2013 |url-status=dead |archive-url=https://web.archive.org/web/20130329203014/http://www.gistsupport.org/about-gist/gist-in-neurofibromatosis-1.php |archive-date=29 March 2013 }}</ref><ref>{{cite web|url=http://clinicaltrials.gov/ct2/show/NCT01140360|title="Pilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform Neurofibromas (0908-09)" (Suspended)|publisher=Clinicaltrials.gov|access-date=3 April 2013|url-status=live|archive-url=https://web.archive.org/web/20130703202412/http://www.clinicaltrials.gov/ct2/show/NCT01140360|archive-date=3 July 2013}}</ref> There have been several [[Phase 2 clinical testing|phase 2]] trials of imatinib for [[aggressive fibromatosis]].<ref>{{cite journal | vauthors = Kasper B, Gruenwald V, Reichardt P, Bauer S, Rauch G, Limprecht R, Sommer M, Dimitrakopoulou-Strauss A, Pilz L, Haller F, Hohenberger P | title = Imatinib induces sustained progression arrest in RECIST progressive desmoid tumours: Final results of a phase II study of the German Interdisciplinary Sarcoma Group (GISG) | journal = European Journal of Cancer | volume = 76 | pages = 60–67 | date = May 2017 | pmid = 28282612 | doi = 10.1016/j.ejca.2017.02.001 | s2cid = 3630670 }}</ref><ref>{{cite journal | vauthors = Mangla A, Agarwal N, Schwartz G | title = Desmoid Tumors: Current Perspective and Treatment | journal = Current Treatment Options in Oncology | volume = 25 | issue = 2 | pages = 161–175 | date = February 2024 | pmid = 38270798 | pmc = 10873447 | doi = 10.1007/s11864-024-01177-5 | doi-access = free }}</ref>
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