Tasigna OK'd for Early Myeloid Leukemia

WASHINGTON, June 21 (UPI) — The U.S. Food and Drug Administration says it has approved the drug Tasigna for treatment of a rare blood cancer when it is first diagnosed.

The FDA said the cancer — Philadelphia chromosome positive chronic phase chronic myeloid leukemia — is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

“Tasigna (nilotinib) is believed to work by blocking a signal that leads to leukemic cell development,” the agency said. “The new indication expands the use of Tasigna to adult patients in earlier stages of the disease. The FDA originally approved Tasigna in October 2007 for the treatment of (the cancer) in adult patients whose disease had progressed or who could not tolerate other therapies, including Gleevec (imatinib).”

The new indication for Tasigna was approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to “treat serious diseases with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit.”

Other FDA-approved drugs to treat chronic myeloid leukemia include Gleevec and Sprycel. Tasigna and Gleevec are marketed by Novartis Pharmaceuticals of East Hanover, N.J. Sprycel is marketed by Bristol-Myers Squibb of New York.

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