Produced in a state-of-the-art production process, this innovative drug is bioequivalent to reference asparaginase and therefore a safe and effective replacement in treatment protocols.
The product was developed to have a low content of protein aggregates. Associated with considerably lower rate of allergic reactions it promises a high compliance rate. Spectrila® has authorisation to be used as part of an antineoplastic combination therapy to treat acute lymphoblastic leukaemia (ALL) in infants and adolescents (from birth to 18 years) as well as in adults.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® 10,000U powder for concentrate for solution is administered once every three days by intravenous infusion. The dosage depends on the patient’s age or body surface area respectively. The active substance in Spectrila® 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.3
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 Medac is able to ensure long-term supply in the United Kingdom with this established therapeutic agent. Accompanying the treatment with Spectrila®, Medac provides a quantitative enzyme test (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 für klinische Spezialpräparate mbH. Summary of product characteristics Spectrila 10,000 U powder for concentrate for solution for infusion, Wedel January 2016.
- Hoelzer D et al, on behalf of the ESMO Guidelines Committee. Acute lymphoblastic leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Apr 7. [Epub ahead of print].
- van den Berg H. Asparaginase revisited. Leuk Lymphoma 2011;52:168-78.