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Ponatinib acts against the most resistant types of chronic myeloid leukemia
Date:11/28/2012

HOUSTON A previously invincible mutation in chronic myeloid leukemia (CML) has been thwarted by an investigational drug in a phase I clinical trial reported in the current edition of The New England Journal of Medicine.

All 12 patients in the trial with chronic phase CML and the T315I mutation had a complete hematologic response (absence of CML cells in the blood) after treatment with ponatinib. Eleven had a major reduction in CML cells in the bone marrow and nine achieved a complete cytogenetic response no cells in the marrow.

T315I is present in up to 20 percent of patients and blocks the docking station where three other successful CML drugs normally connect to the mutant protein.

Ponatinib also induced high response rates among the broader group of patients who had mutations other than T315I or no detectable mutations. Among 65 patients with relapsed or resistant CML at varying stages of the disease or with Philadelphia-chromosome positive acute lymphoblastic leukemia (ALL), 67 percent with other mutations and 46 percent with no mutations achieved a complete cytogenetic response.

Ponatinib is a promising new treatment for patients who have run out of options and its activity against other resistant mutations and in patients with no known mutations suggests a broad range of efficacy for this drug, said trial principal investigator Jorge Cortes, M.D., professor in The University of Texas MD Anderson Department of Leukemia.

Cortes will report the results of a pivotal phase II clinical trial of ponatinib at the 54th ASH Annual Meeting and Exposition in December.

The U.S. Food and Drug Administration in October accepted a new drug application by ARIAD Pharmaceuticals for accelerated review of ponatinib for patients with resistant or intolerant CML or Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

Targeted therapy success story

CML is caused by the abnormal gene
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Contact: Scott Merville
smerville@mdanderson.org
713-792-0661
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert

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