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Second-line CML drugs evoke faster, better front-line remissions
Date:6/5/2010

dose nilotinib, the numbers were 78 percent, 43 percent and also less than 1 percent.

In the imatinib arm, 65 percent achieved complete cytogenetic response, 22 percent reached major molecular response, and 4 percent had their disease progress.

Patients on nilotinib achieved major molecular response earlier than those on imatinib, with median times to MMR of 5.7 and 5.8 months, compared with 8.3 months for imatinib.

Nilotinib and imatinib had favorable safety profiles, with serious side effects uncommon for either drug. Hematologic side effects decreased levels of red blood cells, white blood cells or platelets -- were slightly more common among those on imatinib. Nausea, diarrhea, vomiting, muscle spasms and edema were higher on imatinib, but rash, headache, hair loss and itching were higher on nilotinib.

Novartis, the company that makes imatinib, also developed nilotinib, and Bristol-Myers Squibb developed dasatinib, both of which are more potent inhibitors of the BCR-ABL protein. The two drugs are approved as second-line therapy after imatinib fails or as first therapy for those who cannot take imatinib. Both companies are expected to seek U.S. Food and Drug Administration approval for the two drugs as initial therapy for CML.

"Findings from both of these studies confirm the single-arm trials done at MD Anderson, which had shown superiority of second-generation drugs in a front-line setting," Kantarjian said. The two ongoing single-arm clinical trials, led by Jorge Cortes, M.D., professor in MD Anderson's Department of Leukemia, compare the performance of the drugs in new patients to historical results from earlier trials of imatinib.


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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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