ERYTECH Pharma’s (NASDAQ:ERYP) eryaspase received FDA fast track designation for the second-line treatment of patients with metastatic pancreatic cancer.
Eryaspase is being evaluated in a Phase 3 trial, called TRYbeCA-1, which will enroll some 500 patients. More than 75% of the patients currently enrolled have been randomized to receive eryaspase, in combination with standard chemotherapy, or chemotherapy alone. The study’s primary endpoint is overall survival.
ERYTECH expects an interim superiority analysis to take place around year-end 2020, with a final analysis expected in the second half of 2021.
“[Fast track designation] is yet another significant milestone and meaningful validation of our technology as we continue our TRYbeCA-1 Phase 3 trial evaluating eryaspase in second-line metastatic pancreatic cancer,” Gil Beyen, ERYTECH’s CEO, said in a statement.
“We believe that the FDA’s fast track designation for eryaspase underscores its potential to address this high unmet medical need,” he added.
