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All news ERYTECH Granted U.S. FDA Fast Track Designation for Eryaspase in Hypersensitive ALL
Cambridge, MA (U.S.) and Lyon (France), July 29, 2021 – ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company, leader in red blood-cell based cancer therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted eryaspase Fast Track designation for the treatment of acute lymphocytic leukemia (ALL) patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase (PEG-ASNase).
“This is yet another significant milestone and meaningful inflection point in advancing our lead product candidate eryaspase, further supporting our recently announced intention to submit a BLA for eryaspase in hypersensitive ALL patients,” said Gil Beyen, CEO of ERYTECH. “We believe that the FDA’s Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.”