Novartis' new CML treatment Tasigna outperforms its older drug

FRIMLEY, England A Novartis drug for treating chronic myeloid leukemia outperformed an older Novartis drug in a late-stage clinical trial among patients newly diagnosed with the disease, according to results that the Swiss pharmaceutical company announced at the annual meeting of the American Society of Hematology in New Orleans Tuesday.

Novartis said that after 12 months, “significantly” fewer patients newly diagnosed with CML in the chronic stage exhibiting an abnormality called the Philadelphia chromosome progressed to later stages of the disease while taking Tasigna (nilotinib) than did those taking Gleevec (imatinib). The drug maker plans to file for regulatory approval of Tasigna for newly diagnosed CML patients, though it already has approval from the Food and Drug Administration and other worldwide agencies for treatment of the disease.

The head-to-head study was part of a phase 3 trial of Tasigna enrolling 846 patients around the world who received twice-daily 400 mg or 300 mg doses of Tasigna or once-daily 400-mg doses of Gleevec.

“The impressive rates of response observed in this study, combined with the very low rate of disease progression seen in nilotinib-treated patients are very encouraging,” Royal Liverpool University Hospital professor and study researcher Richard Clark said in a statement.