The German company Medac Gesellschaft fur klinische Spezialpräparate mbH was granted a marketing authorisation for Spectrila® (asparaginase) as part of an antineoplastic combination therapy to treat acute lymphoblastic leukaemia (ALL) in infants and children (from birth to 18 years) as well as in adults. Previously, the Committee for Medicinal Products for Human Use, CHMP (the scientific commission of the European Medicines Agency, EMA), gave a positive opinion in favour of approval in November 2015.
The active substance in Spectrila®, asparaginase produced in a state-of-the-art recombinant production process, is an enzyme that breaks down the amino acid asparagine, thereby reducing the concentration of asparagine in the blood. Since cancer cells rely on this amino acid in order to grow and reproduce, a reduction of the asparagine concentration in the blood leads to leukaemic cell death. In a study performed in children diagnosed with ALL, 95% of the patients treated with Spectrila® showed a complete elimination of asparagine in their blood.1
Asparaginase is an established backbone of treatment for acute lymphoblastic leukaemia and in most treatment protocols it is used in induction as well as in consolidation chemotherapy.2 Spectrila® is administered once every three days by intravenous infusion. The dosage depends on the patient’s age or body surface area respectively.
The successful development and approval of Spectrila® strengthens Medac’s position in the field of haematology. With the EU-wide approval and a newly developed manufacturing process by Wacker Biotech, Medac is able to ensure long-term supply in Germany and Europe with this established therapeutic agent.
Accompanying the treatment with Spectrila®, Medac provides a quantitative enzyme test called “Medac asparaginase activity assay”. By using this test kit it is possible to determine the asparaginase activity during the course of the therapy in order to optimise asparaginase treatment.
- Medac Gesellschaft fur klinische Spezialpräparate mbH, Summary of product characteristics Spectrila 10,000 U powder for concentrate for solution for infusion, Wedel January 2016.
- German Association of Hematology and Oncology, Guideline Acute Lymphoblastic Leukemia (ALL) from February 2012. Please see: https://www.onkopedia-guidelines.info/en/onkopedia/guidelines; van den Berg H. Asparaginase revisited. Leuk Lymphoma 2011;52:168–78.