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Javier Pinilla-Ibarz and Alfonso Quintás-Cardama

The discovery of molecularly targeted agents that selectively inhibit bcr-abl tyrosine kinase activity, such as imatinib, has revolutionized the treatment and natural history of chronic myelogenous leukemia (CML). Treatment of chronic-phase CML with imatinib showed complete cytogenetic response rates of more than 40% in patients after failure of interferon-α, and more than 80% in patients with newly diagnosed CML. Patients with CML can now expect excellent long-term survival, often without major side effects. In most patients, however, residual leukemic burden remains detectable using a sensitive reverse transcription-polymerase chain reaction method. In addition, many patients undergoing imatinib therapy will either not respond or lose their response over time because of resistance or intolerance. The introduction of second-generation tyrosine kinase inhibitors (TKIs) re-establishes response in approximately half of these patients. Several agents are being developed for treating patients who experience suboptimal response to second-generation TKIs and for those who develop resistance caused by the emergence of highly resistant BCR-ABL1 mutations. This article provides an overview of novel targeted agents available for CML.

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Susan O'Brien, Ellin Berman, Joseph O. Moore, Javier Pinilla-Ibarz, Jerald P. Radich, Paul J. Shami, B. Douglas Smith, David S. Snyder, Hema M. Sundar, Moshe Talpaz and Meir Wetzler

recommended doses were 63% and 59%, respectively, at 24-month follow-up. 37 , 40 , 48 MCyR rates were similar in imatinib-resistant patients, whereas the corresponding response rates were higher with dasatinib in the imatinib-intolerant patients in all phases

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Susan O'Brien, Camille N. Abboud, Mojtaba Akhtari, Jessica Altman, Ellin Berman, Daniel J. DeAngelo, Steven Devine, Amir T. Fathi, Jason Gotlib, Madan Jagasia, Joseph O. Moore, Javier Pinilla-Ibarz, Jerald P. Radich, Vishnu V.B. Reddy, Neil P. Shah, Paul J. Shami, B. Douglas Smith, David S. Snyder, Meir Wetzler and Furhan Yunus

: Research Trials of Dasatinib [START]) of dasatinib in patients with imatinib-resistant or imatinib-intolerant Ph-positive leukemias. Resistance to imatinib was defined as failure to experience a CHR within 3 to 6 months, absence of an MCyR by month 12, or

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Hema Sundar and Jerald Radich

imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study . Leukemia 2013 ; 27 : 107 – 112 . 14. Shah NP Guilhot F Cortes JE . Long-term outcome with

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Susan O’Brien, Jerald P. Radich, Camille N. Abboud, Mojtaba Akhtari, Jessica K. Altman, Ellin Berman, Daniel J. DeAngelo, Michael Deininger, Steven Devine, Amir T. Fathi, Jason Gotlib, Madan Jagasia, Patricia Kropf, Joseph O. Moore, Arnel Pallera, Javier Pinilla-Ibarz, Vishnu VB. Reddy, Neil P. Shah, B. Douglas Smith, David S. Snyder, Meir Wetzler, Kristina Gregory and Hema Sundar

. Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study . Leukemia 2013 ; 27 : 107 – 112 . 9. Khoury HJ Cortes JE Kantarjian HM . Bosutinib

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Giuseppe Saglio and Carmen Fava

, dasatinib or nilotinib, whose efficacy as second-line therapy in patients with imatinib-resistant or imatinib-intolerant CML has been clearly shown in several phase II studies. 31 , 32 The best therapeutic strategy to follow for patients with cytogenetic

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Susan O’Brien, Jerald P. Radich, Camille N. Abboud, Mojtaba Akhtari, Jessica K. Altman, Ellin Berman, Peter Curtin, Daniel J. DeAngelo, Michael Deininger, Steven Devine, Amir T. Fathi, Jason Gotlib, Madan Jagasia, Patricia Kropf, Joseph O. Moore, Arnel Pallera, Vishnu VB. Reddy, Neil P. Shah, B. Douglas Smith, David S. Snyder, Meir Wetzler, Kristina Gregory and Hema Sundar

BP-CML. 11 , 31 – 38 Dasatinib, 38 – 41 nilotinib, 38 , 42 , 43 bosutinib, 44 and ponatinib 45 , 46 have shown clinical activity in patients imatinib-resistant or imatinib-intolerant AP-CML or BP-CML. The START-A trial evaluated the safety and

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whose disease was imatinib-resistant, a later switch increased average QALYs by 2.81 and costs by $138,071. For patients with imatinib-intolerant disease, switching later increased average QALYs by 2.59 and costs by $148,402. Patients treated with second

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Jerald P. Radich, Michael Deininger, Camille N. Abboud, Jessica K. Altman, Ellin Berman, Ravi Bhatia, Bhavana Bhatnagar, Peter Curtin, Daniel J. DeAngelo, Jason Gotlib, Gabriela Hobbs, Madan Jagasia, Hagop M. Kantarjian, Lori Maness, Leland Metheny, Joseph O. Moore, Arnel Pallera, Philip Pancari, Mrinal Patnaik, Enkhtsetseg Purev, Michal G. Rose, Neil P. Shah, B. Douglas Smith, David S. Snyder, Kendra L. Sweet, Moshe Talpaz, James Thompson, David T. Yang, Kristina M. Gregory and Hema Sundar

: 869 – 874 . 94. Giles FJ le Coutre PD Pinilla-Ibarz J . Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study . Leukemia 2013 ; 27

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George D. Demetri, Scott Antonia, Robert S. Benjamin, Marilyn M. Bui, Ephraim S. Casper, Ernest U. Conrad III, Thomas F. DeLaney, Kristen N. Ganjoo, Martin J. Heslin, Raymond J. Hutchinson, John M. Kane III, G. Douglas Letson, Sean V. McGarry, Richard J. O'Donnell, I. Benjamin Paz, John D. Pfeifer, Raphael E. Pollock, R. Lor Randall, Richard F. Riedel, Karen D. Schupak, Herbert S. Schwartz, Katherine Thornton, Margaret von Mehren and Jeffrey Wayne

patients (17.4%), compared with no partial responses and stable disease in 2 patients (1.9%) on placebo. In the imatinib-intolerant group, 4 of 9 patients randomized to sunitinib experienced partial response, with progressive disease in only one. In