Novartis cancer drug wins wider U.S. approval

NEW YORK Thu Jun 17, 2010 6:10pm EDT

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NEW YORK (Reuters) - Swiss drugmaker Novartis AG won wider U.S. approval for its leukemia drug Tasigna to treat a rare form of the blood cancer at an earlier stage of the disease, the Food and Drug Administration said on Thursday.

Tasigna had previously been approved to treat adults with chronic myeloid leukemia, or CML, in patients who could not tolerate or were no longer responding to treatment with Gleevec, an older but highly effective Novartis drug.

The new approval could lead to significantly higher sales of Tasigna, known chemically as nilotinib.

In a clinical study presented at a major cancer meeting earlier this month, Tasigna fared better than Gleevec in a head-to-head trial, paving the way for the expanded approval.

About 44 percent of patients taking the newer Novartis pill had a major molecular response compared with 22 percent for Gleevec after 12 months.

A major molecular response is defined by a reduction of disease by 99.9 percent and has been associated with higher rates of long-term survival.

The side effects, or toxicity, seen with Tasigna were less severe than with Gleevec in the head-to-head study, researchers said when presenting the data.

Both Tasigna and Gleevec belong to a class of drugs called tyrosine kinase inhibitors, which deactivate messages that make leukemia cells malignant and kills them.

Bristol-Myers Squibb Co is hoping to win earlier stage approval for its similar CML drug Sprycel, which also topped Gleevec in a recent head-to-head trial.

Any long-term survival improvement the newer drugs can demonstrate over Gleevec would be impressive. The older drug increased the CML 10-year survival rate from less than 20 percent to up to 90 percent and transformed CML from a death sentence to a manageable disease for most patients.

"It's important for companies to continue developing oncology drugs for earlier stages of the disease once they have demonstrated clinical effectiveness in resistant forms of cancer," Dr Richard Pazdur, director of the Office of Oncology Drug Products for the FDA's Center for Drug Evaluation and Research, said in a statement.

"This approach has the potential to increase the availability of an effective treatment to more patients," he added.

(Reporting by Bill Berkrot; Editing by Tim Dobbyn)

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