FRIDAY, Nov. 18 (HealthDay News) -- Erwinaze (asparaginase Erwinia chrysanthemi) has been approved by the U.S. Food and Drug Administration to treat Acute Lymphoblastic Leukemia (ALL) among people who have developed an allergy to more standard treatments.
Typically, treatments include asparaginase and pegaspargase chemotherapy drugs. But some patients develop allergies to these medications.
Newly approved Erwinaze, injected intramuscularly three times weekly, breaks down a protein building block that helps leukemia cells grow. Without this protein, the leukemia cells die, the FDA said in a news release.
The safety and effectiveness of Erwinaze were evaluated in clinical studies involving 58 people. Additional safety data were harvested from a separate trial involving 843 patients, the FDA said. Observed side effects of Erwinaze included severe allergic reactions, pancreatic inflammation, high liver enzymes, abnormal bleeding or clotting, nausea, and hyperglycemia.
Erwinaze has been designated an orphan drug, since ALL affects fewer than 200,000 people in the United States, the FDA said.
The drug is produced by EUSA Pharma Inc., based in Langhorne, Pa.
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