FDA expands approval of Novartis cancer drug

NEW YORK

The Food and Drug Administration on Thursday said it approved Novartis AG's drug Tasigna as an initial treatment for a type of blood cancer called chronic myeloid leukemia.

Tasigna was cleared as a treatment for patients newly diagnosed with the disease. Chronic myeloid leukemia is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

The drug is already approved as a treatment for patients with chronic myeloid leukemia who received a prior treatment. Novartis also makes the blockbuster chronic myeloid leukemia drug Gleevec, which is approved as an initial treatment.

In a late stage study, Tasigna prompted a reduction in cancer cells in 44 percent of patients, compared with 22 percent on Gleevec.

According to the FDA, in chronic myeloid leukemia, too many blood stem cells develop into a type of white blood cell called granulocytes. The granulocytes are abnormal and do not become healthy white blood cells, which then build up in the blood and bone marrow, blocking room for healthy cells. The result can range from infection to anemia.

Bristol-Myers Squibb Co. makes the chronic myeloid leukemia treatment Sprycel.

Shares of Novartis fell 32 cents to $48.68 in afternoon trading Friday.