What is Erwinase
Erwinase® (crisantaspase) is an L-asparaginase enzyme derived from the bacterium Erwinia Chrysanthemi that is indicated for the treatment of Acute Lymphoblastic Leukaemia (ALL) a type of cancer that particularly affects children.
Developed at Porton in the 1960’s, PBL remains the sole global manufacturer of Erwinase® which was first registered as a product name in the UK in 1985. Since then it has been supplied to treat patients in numerous countries around the world.
Approval was obtained from the US Food and Drug Administration (FDA) in 2011 following the submission of a Biological Licence Application (BLA) in the name of Erwinaze®.
Supply of Erwinase®
Supply of Erwinase® manufactured and licensed in the UK (PL44403/0002) is available for order from Clinigen via
- Medical Access (MedicineAccess@clinigengroup.com)
- or by calling+44 (0) 1283 494 340
Since announcing a new exclusive world-wide licensing agreement for the distribution of the product with Clinigen from January 2021, PBL has pursued a strategy of obtaining Marketing Authorisations in its name in numerous territories. This includes:
- Under the name of Crisantaspase porton biopharma in the Netherlands in October 2020
- followed by Mutual Recognition in France, Germany Ireland, Spain and Portugal.
Do also visit our News Page to check for the latest updates on the roll-out, or supply in various territories.
About Erwinase®
Erwinase® is a well established global product indicated for the treatment of Acute Lymphoblastic Leukaemia (ALL), a type of cancer that particularly affects children. Since its first licensure in the UK in 1985 Erwinase® has treated more than 90,000 patients globally over the last 36 years. The product has a well characterised safety profile and is familiar to healthcare professionals in many countries.
Erwinase® is an asparaginase enzyme derived from the bacterium Erwinia chrysanthemi that is used as part of the treatment protocols in conjunction with radiotherapy or chemotherapy.
Asparagine is an amino acid that is essential for cell growth; it is produced by most but not all cells. Mutated cancer cells in ALL rely on asparagine circulating in the blood for growth. L-asparaginases are a group of enzymes that lower circulating asparagine levels in the blood, thereby depriving the mutated cells of asparagine and inhibiting their growth.
There are several different types of L-asparaginase available on the market, each derived from a different bacterium. Patients receiving treatment with L-asparaginase derived from Escherichia coli (E. coli), who develop hypersensitivity to that form of the enzyme, may be able to continue treatment with Erwinase® as the enzymes are immunologically distinct. Antibodies targeting E. coli derived L-Asparaginase have been shown not to cross-react with Erwinase®.
Erwinase®Reconstitution Process
To aid healthcare professionals this instructional video demonstrates the correct technique to reconstitute the product.
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