FDA OKs new chronic myeloid leukemia drug

WASHINGTON, Oct. 30 (UPI) -- The U.S. Food and Drug Administration has approved Tasigna (nilotinib) capsules for treatment of Philadelphia chromosome positive chronic myeloid leukemia.

The drug was approved for use by adult patients whose disease has progressed or who cannot tolerate other therapies that included Gleevec. That drug (imatinib) is approved for the treatment of newly diagnosed patients with Philadelphia chromosome positive CML.

The FDA's approval of Tasigna includes a black box warning for possible life-threatening heart problems that might lead to an irregular heartbeat and possible sudden death.

"This represents another treatment option for CML patients who are resistant to or can no longer tolerate imatinib," said Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs. "Patients should consult with their physicians, however, because of possible life-threatening heart problems associated with this drug."

Chronic myeloid leukemia accounts for 15 percent of all leukemias in adults, with approximately 4,500 new cases expected to be diagnosed this year.

Tasigna is manufactured by the Novartis Pharmaceuticals Corp. of East Hanover, N.J.