On October 10, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it has resubmitted to the European Medicine Agency (EMA) its Marketing Authorization Application (MAA) for eryaspase (GRASPA) for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL) (Press release, ERYtech Pharma, OCT 10, 2017, View Source [SID1234520866]). The MAA resubmission includes the data from ERYTECH’s GRASPALL 2009-06 Phase 2/3 clinical trial in children and adults with R/R ALL as well as additional data to address the outstanding questions of the Committee for Medicinal Products for Human Use (CHMP) of the EMA.

The GRASPALL Phase 2/3 trial, showed positive efficacy and safety results with GRASPA in combination with chemotherapy as compared to native L-asparaginase in patients with R/R ALL. The patients treated with GRASPA experienced a mean duration of L-asparaginase activity that was almost twice as long as for patients receiving native L-asparaginase. GRASPA also had a favorable safety profile in the trial and no patients who received GRASPA experienced an allergic reaction, as compared to 46% of the patients who received native L-asparaginase. Patients in the GRASPA treatment arm also had overall higher complete remission rates during induction, and GRASPA was associated with fewer drug-related adverse events.

In November 2016, ERYTECH withdrew its original MAA to allow sufficient time to provide the additional data requested in the CHMP’s Day 180 List of Outstanding Issues. ERYTECH has now resubmitted its MAA with additional data from studies on comparability, immunogenicity, and pharmacodynamic effects.

Gil Beyen, CEO and Chairman of ERYTECH, said: “Our teams have worked hard over the past weeks and months to address and compile additional data for the resubmission of the MAA for potential approval of GRASPA as a treatment for ALL. We believe these data have further strengthened our dossier for European marketing authorization. We strongly believe in the potential of our drug candidate and are looking forward to working with the EMA during the review process.”

Dr. Iman El-Hariry, Chief Medical Officer of ERYTECH, added: “We are delighted to complete the resubmission of the MAA for GRASPA in R/R ALL. Asparaginase continues to play an important role in treatment of newly diagnosed patients with R/R ALL. ERYTECH is committed to developing an effective therapy to patients with ALL and improving patient outcomes.”

About Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia (ALL) is a blood cancer affecting mainly the white blood cells. ALL is most prevalent in children between the ages of two and five, although adults are also affected. The American Cancer Society estimates that approximately 5,970 new cases of ALL will be diagnosed in the United States in 2017, resulting in approximately 1,440 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%.