Accueil   Diary - News   All news ERYTECH Granted U.S. FDA Fast Track Designation for Eryaspase in Hypersensitive ALL

ERYTECH Granted U.S. FDA Fast Track Designation for Eryaspase in Hypersensitive ALL

 

Fast Track designation for eryaspase underscores the need for new treatment options for patients who developed hypersensitivity reactions to pegylated asparaginase

 

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 therapeuticsannounced 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.

 

Read the press release