Evolution In EGFRM+ Lung Cancer

Published by Sakshi Saini at August 16, 2018

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Click here for References

EGFR Gene – Discovery and Pathway/Resistance Mechanisms
https://febs.onlinelibrary.wiley.com/doi/pdf/10.1111/j.1742-4658.2009.07448.x
http://clincancerres.aacrjournals.org/content/21/10/2213
https://www.cell.com/action/showImagesData?pii=S0165-6147%2816%2930111-0
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504488.htm
http://abstracts.asco.org/214/AbstView_214_225587.html
https://molecular-cancer.biomedcentral.com/track/pdf/10.1186/s12943-018-0778-0

4th Gen EGFR Inhibitor

Tarceva (erlotinib)
https://www.gene.com/media/press-releases/7947/2004-11-18/fdaapproves-tarceva-for-patients-with-a
https://www.ncbi.nlm.nih.gov/pubmed/21148614
https://www.businesswire.com/news/home/20100428007263/en/OSIPharmaceuticals-Announces-Tarceva%C2%AE-Received-Approval-European
https://www.ncbi.nlm.nih.gov/pubmed/24868098
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm525739.htm
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504488.htm
https://www.roche.com/media/releases/med-cor-2011-09-01.htm
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000618/WC500033994.pdf
https://www.roche.com/investors/updates/inv-update-2007-10-22.htm
https://www.roche.com/dam/jcr:e3386f51-b285-4a76-8514-ee7e53a805f0/en/inv-update-2013-06-14b-annex.pdf
https://www.roche.com/media/releases/med-cor-2016-06-08.htm
https://meetinglibrary.asco.org/record/61483/abstract
https://www.medscape.com/viewarticle/706862#vp_1
https://www.nejm.org/doi/full/10.1056/NEJMoa050753
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70381-X/abstract?code=lancet-site
https://www.ncbi.nlm.nih.gov/pubmed/27987585

Iressa (gefitinib)
http://theoncologist.alphamedpress.org/content/8/4/303.full
https://www.cell.com/action/showImagesData?pii=S0165-6147%2816%2930111-0
https://www.astrazeneca.com/media-centre/press-releases/2009/IRESSAGefitinib-Receives-Marketing-Authorisation-01072009.html#
https://jamanetwork.com/journals/jama/fullarticle/197532
https://www.citizen.org/our-work/health-and-safety/supplement-petitionban-gefitinib-iressa
https://www.astrazeneca-us.com/media/press-releases/2015/iressaapproved-by-the-fda-20150713.html#
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3887309/
https://www.medscape.com/viewarticle/707751
http://ascopubs.org/doi/full/10.1200/JCO.2009.24.3030
http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=28010
http://www.npojip.org/iressa/iressaISDB-Feb-2.html
https://www.theguardian.com/business/2005/jan/05/1
https://www.ncbi.nlm.nih.gov/pubmed/12748244
https://www.nature.com/articles/6601550
http://www.yakugai.gr.jp/topics/file/en/Masumi%20Minaguchi20slides(English).pdf
http://ascopubs.org/doi/full/10.1200/JCO.2003.10.038
https://academic.oup.com/jjco/article/40/suppl_1/i7/947384
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206995s000lbl.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Public_assessment_report/human/001016/WC500036361.pdf

Rociletinib
https://www.businesswire.com/news/home/20150803005147/en/Clovis-Oncology-Completes-U.S.-E.U.-Regulatory-Submissions
https://www.curetoday.com/articles/fda-panel-advises-against-approval-ofrociletinib-in-lung-cancer
https://www.onclive.com/web-exclusives/clovis-ends-development-ofrociletinib-in-lung-cancer

ASP8273
https://www.fiercebiotech.com/biotech/astellas-scraps-nsclc-programafter-look-at-phase-3-data

Tagrisso (osimertinib)
https://www.astrazeneca.com/media-centre/pressreleases/
2015/TAGRISSO-AZD9291-approved-by-the-US-FDA-for-patientswith-EGFR-T790M-mutation-positive-metastatic-non-small-cell-lung-cancer-13112015.html#
https://www.cell.com/action/showImagesData?pii=S0165-6147%2816%2930111-0
https://www.astrazeneca-us.com/media/press-releases/2016/us-fdaapproves-tagrisso-osimertinib-blood-based-t790m-companion-diagnostictest-09292016.html
https://www.astrazeneca.com/media-centre/press-releases/2016/tagrissoosimertinib-approved-in-eu-as-first-in-class-treatment-for-lung-cancer-03022016.html#
https://www.astrazeneca.com/media-centre/press-releases/2018/us-fdaapproves-tagrisso-as-1st-line-treatment-for-EGFR-mutated-non-small-celllung-cancer.html
https://www.astrazeneca.com/media-centre/press-releases/2018/the-euapproves-tagrisso-for-1st-line-treatment-of-egfr-mutated-non-small-celllung-cancer-08062018.html
https://www.astrazeneca.com/media-centre/press-releases/2016/tagrissodemonstrates-superiority-over-chemotherapy-in-egfr-t790m-mutationpositive-non-small-cell-lung-cancer-06122016.html
https://globenewswire.com/newsrelease/2016/03/29/823416/0/en/TAGRISSO-APPROVED-IN-JAPAN-FORCANCER-PATIENTS.html
https://www.businesswire.com/news/home/20150908006803/en/AstraZeneca-Presents-Evidence-Potential-

AZD9291-First-Line-Pre-Treated
https://www.astrazeneca.com/media-centre/pressreleases/
2017/astrazeneca-tagrisso-shows-potential-as-a-new-standard-ofcare-in-1st-line-egfr-mutated-lung-cancer-at-esmo-2017-congress-08092017.html
http://pj.jiho.jp/servlet/pjh/business/outline/1226591501001.html
https://academic.oup.com/annonc/article/26/10/2073/144546
https://www.astrazeneca.com/media-centre/medical-releases/newengland-journal-of-medicine-publishes-results-of-phase-iii-flaura-trial-inthe-1st-line-treatment-of-egfr-mutated-non-small-cell-lung-cancer-20112017.html

Dacomitinib
http://press.pfizer.com/press-release/us-fda-and-european-medicinesagency-accept-regulatory-submissions-review-dacomitinib

https://meetinglibrary.asco.org/record/145472/abstract
https://oncology.medicinematters.com/non-small-cell-lungcancer/dacomitinib/archer-1050–dacomitinib-hits-the-os-target-inadvanced-egfr-mut/15847706
https://investors.pfizer.com/investor-news/press-releasedetails/2018/Dacomitinib-Shows-More-than-Seven-Month-Improvement-in-Overall-Survival-Compared-to-an-Established-Therapy-in-Advanced-NSCLCwith-EGFR-Activating-Mutations/default.aspx

Giotrif (afatinib)
https://www.boehringer-ingelheim.com/press-release/asco-2013-newdata-lux-lung-6-and-lume-lung-2
https://www.haigekassa.ee/sites/default/files/TTL/register_2015/lisaandmed/1074_lisaandmed.pdf”
https://www.boehringer-ingelheim.us/press-release/fda-approves-gilotrifafatinib-first-line-treatment-metastatic-non-small-cell-lung
https://www.boehringer-ingelheim.com/press-release/giotrif-afatinibapproved-europe-patients-egfr-mutation-positive-lung-cancer
http://www.pmda.go.jp/english/review-services/reviews/approvedinformation/drugs/0001.html
https://www.boehringer-ingelheim.us/press-release/fda-approves-newindication-gilotrif-egfr-mutation-positive-nsclc
http://www.ascopost.com/News/22656
http://www.poster-submission.com/cdrom/download_poster/37/27657/1251P
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s001lbl.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002280/WC500152392.pdf

Olmutinib
https://www.biospace.com/article/deaths-lead-boehringer-ingelheim-tocancel-730-million-cancer-deal-with-hanmi-pharma-b-hanmi-b-stocktanks-/
https://www.firstwordpharma.com/node/1556696?tsid=33

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Sakshi Saini

Sakshi has a passion for healthcare and innovation in medical techs (Rx and devices). Her ability lies in providing an "outside-in" perspective to colleagues involved in the design, development and commercialization of medical innovation. She comes with a wide range of experience in the oncology space pertaining to both solid tumors and blood malignancies (Lung, Colorectal, Melanoma,AML and MDS).She works with RAS clients to provide activities related to market research and competitive intelligence. She is also a member of European Society of Clinical Oncology.