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.
In this type of cancer, bone marrow produces too many
infection-fighting white blood cells called lymphocytes. Typically,
treatments include asparaginase and pegaspargase chemotherapy
drugs. But some patients develop allergies to these
medications.
Newly approved Erwinaze, injected into a muscle three times
weekly, breaks down a protein building block that helps
overabundant white blood cells (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 was
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 high blood sugar.
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.
More information
Medline Plus has more about
this form of cancer.