The MAA for GRASPA, ERYTECH’s lead product, consisting of asparaginase encapsulated in red blood cells, is based on the positive findings of the pivotal GRASPALL 2009-06 Phase 2/3 study in children and adults with relapsed ALL.
In the GRASPALL Phase 2/3 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 (p<0.001), 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 (p<0.001).
Patients treated with GRASPA also experienced an improvement in complete remission (CR) rate (p=0.024) 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.
ERYTECH Pharma CEO and chairman Gil Beyen said: "I am delighted that we have submitted this application to the EMA. It represents an important achievement in the company’s efforts to bring a meaningful therapeutic option to patients and families with acute lymphoblastic leukemia and a significant milestone in ERYTECH’s development."
ERYTECH chief medical officer Iman El-Hariry said: "We were able to reach this point because of the extraordinary effort of the employees at ERYTECH, the investigators for the clinical trials and most importantly, the patients who participated in the clinical trials and their families.We are looking forward to the potential to offer patients with ALL another effective treatment option with a favorable safety profile."
About Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia (ALL) is a blood cancer affecting mainly the white blood cells. ALL is most prevalent for children between the ages of two and five, although adults are also affected. The American Cancer Society estimates that approximately 6,250 new cases of ALL will be diagnosed in the United States in 2015, resulting in over 1,400 deaths.
Based on incidence data published in scientific literature, ERYTECH estimates that there are at least as many new cases of ALL diagnosed each year in Europe as in the United States. The risk for developing ALL declines slowly after the age of five until the mid-20s and then begins to rise again slowly after the age of 50.
Although most cases of ALL occur in children, approximately 80% of deaths from ALL occur in adults. Pediatric ALL patients have a five-year survival rate of approximately 90%, while the five-year survival rate for adults drops to approximately 30% and for seniors to approximately 15%.