ERYTECH Pharma (NASDAQ: ERYP) has reported that the U.S. Food and Drug Administration has granted eryaspase Fast Track designation for treatment of acute lymphocytic leukemia in patients who have developed hypersensitivity reactions to E. coli derived pegylated asparaginase. “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.”
Asparaginase has been crucial in ALL treatment for years but has been associated with limitations (hypersensitivity) in up to 30% of patients. The discontinuation of asparaginase therapy in ALL patients have been associated with weak event free survival that highlights the demand for additional asparaginase based treatment options.
The Fast Track program is set up to facilitate the expedited development and review of a new drug to treat serious/life-threatening conditions to demonstrate the potential to address an unmet medical need. The idea is to advance new drugs early on for patients who need them.