Erytech Pharma announces FDA acceptance of eryaspase IND application
Erytech Pharma announced the acceptance by the FDA of its investigational new drug, or IND, application for eryaspase, consisting of the enzyme L-asparaginase encapsulated inside donor derived red blood cells. The acceptance of the IND will enable Erytech to initiate enrollment at U.S. trial sites for its ongoing pivotal Phase 3 TRYbeCA1 trial evaluating eryaspase in second-line pancreatic cancer. TRYbeCA1 is expected to enroll approximately 500 patients with second-line metastatic pancreatic cancer at more than 120 clinical sites in Europe and the United States. In this trial, eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival. An interim efficacy analysis is planned for when approximately two-thirds of events have occurred. The trial is now actively enrolling patients in several European countries. The notification for the study to proceed in the U.S. comes in addition to clinical trial authorizations received in eleven European countries.