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Erlotinib hydrochloride

Erlotinib hydrochloride is the hydrochloride salt of a quinazoline derivative with antineoplastic properties. Competing with adenosine triphosphate, erlotinib reversibly binds to the intracellular catalytic domain of epidermal growth factor receptor (EGFR) tyrosine kinase, thereby reversibly inhibiting EGFR phosphorylation and blocking the signal transduction events and tumorigenic effects associated with EGFR activation. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus).

According to wikipedia.com; Erlotinib hydrochloride (Tarceva) is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is a tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR). It is marketed in the United States by Genentech and OSI Pharmaceuticals and elsewhere by Roche.

Erlotinib is an EGFR inhibitor. The drug follows Iressa gefitinib, which was the first drug of this type. Erlotinib specifically targets the epidermal growth factor receptor (EGFR) tyrosine kinase, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor. For the signal to be transmitted, two members of the EGFR family need to come together to form a homodimer. These then use the molecule of ATP to autophosphorylate each other, which causes a conformational change in their intracellular structure, exposing a further binding site for binding proteins that cause a signal cascade to the nucleus. By inhibiting the ATP, autophosphorylation is not possible and the signal is stopped.

In November 2005, the U.S. Food and Drug Administration (FDA) approved the use of erlotinib in combination with gemcitabine for treatment of locally advanced, unresectable, or metastatic pancreatic cancer. The drug's US patent will expire in 2020. In India, generic pharmaceutical firm Cipla is battling with Roche against the Indian patent for this drug. In April 2009, the Delhi High Court granted a final approval to Cipla to manufacture and sell its generic version of Erlotinib in India.  Meanwhile, another generic pharmaceutical firm - Natco is also seeking to manufacture the generic version of Erlotinib in India but sell it to patients in Nepal using the TRIPS Agreements' Doha Declaration.

In November 2008 a study undertaken by Roche Holding of Switzerland claimed that Tarceva given immediately after chemotherapy may prove to stem the progress of lung cancer. Tarceva blocked the spread of advanced non-small cell lung cancer, researchers found. However, the report of this study, called SATURN, does not indicate the extent of increase in survival-time.

Current developer:  Genentech and OSI Pharmaceuticals

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24: Raizer JJ, Abrey LE, Lassman AB, Chang SM, Lamborn KR, Kuhn JG, Yung WK, Gilbert MR, Aldape KD, Wen PY, Fine HA, Mehta M, Deangelis LM, Lieberman F, Cloughesy TF, Robins HI, Dancey J, Prados MD; North American Brain Tumor Consortium. A phase I trial of erlotinib in patients with nonprogressive glioblastoma multiforme postradiation therapy, and recurrent malignant gliomas and meningiomas. Neuro Oncol. 2010 Jan;12(1):87-94. Epub 2009 Dec 14. PubMed PMID: 20150371.

25: Haura EB, Tanvetyanon T, Chiappori A, Williams C, Simon G, Antonia S, Gray J, Litschauer S, Tetteh L, Neuger A, Song L, Rawal B, Schell MJ, Bepler G. Phase I/II study of the Src inhibitor dasatinib in combination with erlotinib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Mar 10;28(8):1387-94. Epub 2010 Feb 8. PubMed PMID: 20142592.

26: Bayraktar S, Bayraktar UD, Rocha-Lima CM. Recent developments in palliative chemotherapy for locally advanced and metastatic pancreas cancer. World J Gastroenterol. 2010 Feb 14;16(6):673-82. Review. PubMed PMID: 20135714; PubMed Central PMCID: PMC2817054.

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32: Kim HS, Lee GW, Kim JH, Kim HY, Kwon JH, Song HH, Kim HJ, Jung JY, Jang G, Choi DR, Park SM, Shin TR, Lee HS, Zang DY. A phase II study of pemetrexed and carboplatin as a salvage therapy for platinum-pretreated patients with non-small cell lung cancer. Lung Cancer. 2010 Jan 20. [Epub ahead of print] PubMed PMID: 20096475.

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35: Pruthi RS, Nielsen M, Heathcote S, Wallen EM, Rathmell WK, Godley P, Whang Y, Fielding J, Schultz H, Grigson G, Smith A, Kim W. A phase II trial of neoadjuvant erlotinib in patients with muscle-invasive bladder cancer undergoing radical cystectomy: clinical and pathological results. BJU Int. 2010 Jan 19. [Epub ahead of print] PubMed PMID: 20089114.

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42: Amann JM, Lee JW, Roder H, Brahmer J, Gonzalez A, Schiller JH, Carbone DP. Genetic and proteomic features associated with survival after treatment with erlotinib in first-line therapy of non-small cell lung cancer in Eastern Cooperative Oncology Group 3503. J Thorac Oncol. 2010 Feb;5(2):169-78. PubMed PMID: 20035238.

43: Hainsworth JD, Spigel DR, Thompson DS, Murphy PB, Lane CM, Waterhouse DM, Naot Y, Greco FA. Paclitaxel/carboplatin plus bevacizumab/erlotinib in the first-line treatment of patients with carcinoma of unknown primary site. Oncologist. 2009 Dec;14(12):1189-97. Epub 2009 Dec 4. PubMed PMID: 19965914.

44: Peereboom DM, Shepard DR, Ahluwalia MS, Brewer CJ, Agarwal N, Stevens GH, Suh JH, Toms SA, Vogelbaum MA, Weil RJ, Elson P, Barnett GH. Phase II trial of erlotinib with temozolomide and radiation in patients with newly diagnosed glioblastoma multiforme. J Neurooncol. 2009 Dec 4. [Epub ahead of print] PubMed PMID: 19960228.

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48: Bijnsdorp IV, Kruyt FA, Fukushima M, Smid K, Gokoel S, Peters GJ. Molecular mechanism underlying the synergistic interaction between trifluorothymidine and the epidermal growth factor receptor inhibitor erlotinib in human colorectal cancer cell lines. Cancer Sci. 2010 Feb;101(2):440-7. Epub 2009 Sep 29. PubMed PMID: 19886911.

49: Mack PC, Holland WS, Burich RA, Sangha R, Solis LJ, Li Y, Beckett LA, Lara PN Jr, Davies AM, Gandara DR. EGFR mutations detected in plasma are associated with patient outcomes in erlotinib plus docetaxel-treated non-small cell lung cancer. J Thorac Oncol. 2009 Dec;4(12):1466-72. PubMed PMID: 19884861.

50: Gordon MS, Hussey M, Nagle RB, Lara PN Jr, Mack PC, Dutcher J, Samlowski W, Clark JI, Quinn DI, Pan CX, Crawford D. Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer: SWOG S0317. J Clin Oncol. 2009 Dec 1;27(34):5788-93. Epub 2009 Nov 2. PubMed PMID: 19884559; PubMed Central PMCID: PMC2793000.

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71: Norden AD, Raizer JJ, Abrey LE, Lamborn KR, Lassman AB, Chang SM, Yung WK, Gilbert MR, Fine HA, Mehta M, Deangelis LM, Cloughesy TF, Robins HI, Aldape K, Dancey J, Prados MD, Lieberman F, Wen PY. Phase II trials of erlotinib or gefitinib in patients with recurrent meningioma. J Neurooncol. 2010 Jan;96(2):211-7. Epub 2009 Jun 28. PubMed PMID: 19562255.

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74: Ansari J, Palmer DH, Rea DW, Hussain SA. Role of tyrosine kinase inhibitors in lung cancer. Anticancer Agents Med Chem. 2009 Jun;9(5):569-75. PubMed PMID: 19519298.

75: Wong HH, Lemoine NR. Pancreatic cancer: molecular pathogenesis and new therapeutic targets. Nat Rev Gastroenterol Hepatol. 2009 Jul;6(7):412-22. Epub 2009 Jun 9. Review. PubMed PMID: 19506583.

76: Landriscina M, Piscazzi A, Fabiano A, Maddalena F, Costantino E, Farese A, Bufo P, Cignarelli M. Targeting epidermal growth factor receptor 1 signaling in human thyroid-stimulating hormone-independent thyroid carcinoma FRO cells results in a more chemosensitive and less angiogenic phenotype. Thyroid. 2009 Jun;19(6):629-37. PubMed PMID: 19499990.

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80: Homs MY, Voest EE, Siersema PD. Emerging drugs for esophageal cancer. Expert Opin Emerg Drugs. 2009 Jun;14(2):329-39. Review. PubMed PMID: 19453287.

81: Rosell R, Perez-Roca L, Sanchez JJ, Cobo M, Moran T, Chaib I, Provencio M, Domine M, Sala MA, Jimenez U, Diz P, Barneto I, Macias JA, de Las Peñas R, Catot S, Isla D, Sanchez JM, Ibeas R, Lopez-Vivanco G, Oramas J, Mendez P, Reguart N, Blanco R, Taron M. Customized treatment in non-small-cell lung cancer based on EGFR mutations and BRCA1 mRNA expression. PLoS One. 2009;4(5):e5133. Epub 2009 May 5. PubMed PMID: 19415121; PubMed Central PMCID: PMC2673583.

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