FDA stamps approval on Eusa Pharma's orphan leukemia drug

U.S. regulators have given a market green light for Eusa Pharma's enzyme drug Erwinaze for a subset of patients with acute lymphoblastic leukemia who have immune reactions to an existing version of the therapy made with E. coli, the company said today. The newly approved drug might only serve a relatively small pool of ALL patients, but it's also the only drug on the U.S. market that addresses the particular problem these patients face with the E. coli-derived drugs.

Rather than making its version of asparaginase with E. coli, Eusa's Erwinaze is made from a closely related organism called Erwinia chrysanthemi. The immune reactions happen in about 15%-20% of ALL patients, mostly children, who take the E. coli-derived asparaginase as part of a standard course of treatment against the blood cancer. The FDA's approval follows a 58-patient pivotal study, in which all the patients reached the primary goal of asparaginase activity, according to Eusa.

"Treatment with asparaginase is a vital and life-saving therapy for thousands of patients, mostly children, with acute lymphoblastic leukemia each year," Dr. Stephen Sallan, chief of staff at Dana-Farber Cancer Institute and a professor of pediatrics at Harvard Medical School, said in statement. "Unfortunately, a number of these patients develop hypersensitivity to asparaginases derived from E. coli, including pegaspargase, and are unable to complete the recommended course of treatment."

Eusa, which has operations in Oxford, England, and Langhorne, PA, plans to make the new drug available to patients right away.

- here's the release