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FDA Gives Nod to New Leukemia Treatment‎

The FDA has approved a new compound for the treatment of acute lymphoblastic leukemia (ALL) patients who are allergic to asparaginase derived from Escherichia coli.

The agency gave the okay to asparaginase Erwinia chrysanthemi (Erwinaze) as a replacement for E. coli-derived asparaginase or pegylated asparaginase (pegaspargase).

The compound is already approved in Canada, the U.K., and several European countries, according to its manufacturer, EUSA Pharma of Langhorne, Pa.

About 2,900 people under 20 are diagnosed with ALL in the U.S. every year, making it the most common form of childhood cancer. It is also one of the most curable forms, with remission rates after treatment of more than 95% and five-year recurrence-free rates reaching 85%.

Treatment typically involves a multi-agent regimen, including asparaginase.

The compound breaks down circulating asparagine, an amino acid that is essential for the growth of cells. Normal cells can make their own, but leukemia cells cannot and must absorb what they need from the blood, so that reducing levels of circulating asparagine inhibits their growth.

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