GEN Exclusives

More »

GEN News Highlights

More »
Nov 18, 2011

FDA Clears EUSA’s Asparaginase Therapy Erwinaze for Acute Lymphoblastic Leukemia

  • FDA approved EUSA Pharma’s orphan drug Erwinaze™ (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase. The firm says the product is the only approved treatment option for patients with hypersensitivity to standard-of-care therapy using E.coli-derived pegaspargase.

    Current treatment protocols for ALL typically involve asparaginase, but an estimated 15–20% of ALL patients develop hypersensitivity to E. coli-derived asparaginase, which equates to about 450–600 children in the U.S. every year, EUSA claims. Approval of Erwinaze in the U.S. was based on data from clinical studies in 630 ALL patients, including a pivotal study in 58 patients in which 100% of evaluable patients achieved the asparaginase activity primary endpoint.

    Founded in 2006, specialty pharmaceutical company EUSA is focused on in-licensing, developing, and marketing late-stage oncology, oncology supportive care, and critical care products. The firm has nine products on the market, including Erwinase and Kidrolase® for treatment of acute lymphoblastic leukemia, Caphosol® for the treatment of oral mucositis, an antibiotic surgical implant Collatamp®, ProstaScint® for imaging the extent and spread of prostate cancer, and Quadramet® for the treatment of pain in bone metastatic cancer patients. EUSA also has several products in late-stage development, including the monoclonal antibody Leukotac®, which is undergoing Phase III trials for the treatment of steroid resistant acute graft versus host disease.

Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content


GEN Jobs powered by connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »

Be sure to take the GEN Poll

Patient Access to Genetic Information

Do you think patients have the absolute right to gain access to their own genetic information from medical or clinical laboratories?

More »