Graspa/Ery-Asp (human erythrocytes encapsulating L-asparaginase) filed with EMA for acute lymphoblastic leukemia- Erytech Pharma

Erytech Pharma has submitted a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Graspa/Ery-Asp (human erythrocytes encapsulating L-asparaginase) for the treatment of patients with acute lymphoblastic leukemia (ALL). The MAA is based on the positive findings of the pivotal GRASPALL 2009-06 Phase II/III study in children and adults with relapsed ALL.

In the GRASPALL study, the results of which were reported in December 2014, Graspa in combination with chemotherapy was observed to result in improved clinical activity and tolerability as compared to native L-asparaginase in patients with relapsed ALL. The mean duration of asparaginase activity above 100 IU/L was 20.5 days in the Graspa group versus 9.6 days in the control arm of patients treated with native L-asparaginase in combination with chemotherapy, and patients in the study treated with GRASPA also demonstrated a significantly lower incidence of hypersensitivity reactions as compared to those in the control arm. Patients treated with Graspa also experienced an improvement in complete remission rate as compared to those in the control arm. Treatment with Graspa was generally well tolerated, and those treated with Graspa also had a lower incidence of adverse events, such as coagulation disorders, pancreatic toxicities and hepatic toxicities, than those treated with native L-asparaginase.