Novartis AG, Europe’s biggest drugmaker, won approval to expand the use of its top-selling drug, Gleevec, to children newly diagnosed with the most common pediatric cancer.
The therapy can be used against a form of acute lymphoblastic leukemia that affects about 2,900 children a year, the U.S. Food and Drug Administration said today in a statement. The cancer causes the bone marrow to produce too many immature white blood cells, crowding out the healthy cells needed to fight infection, and spreads rapidly if untreated.
Gleevec, first approved for leukemia in 2001, generated $4.68 billion in sales last year, according to data compiled by Bloomberg. Its patent protection against generic competitors runs out next year, and Basel, Switzerland-based Novartis has been trying to shift patients to a new treatment, Tasigna.
Today’s approval means “the number of cancer medications for children are on the rise,” Richard Pazdur, the FDA’s director of hematology and oncology products, said in the statement.
Gleevec had been cleared for children previously diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia who had relapsed. The drug should be used in combination with chemotherapy, the agency said. Its most common side effects are a decrease in infection-fighting blood cells, a reduction in blood platelets that help clotting, liver toxicity and infections, the FDA said.
Gleevec blocks proteins called tyrosine kinases that promote the development of cancerous cells, the FDA said. The therapy’s introduction led a group of targeted drugs that have helped eradicate childhood blood cancers in 90 percent of patients during the past decade.