ERYTECH Pharma (NASDAQ: ERYP) has received a Fast Track designation from the US FDA for eryspase for treating acute lymphocytic leukemia (ALL) patients that have developed E. coli—derived pegylated asparaginase hypersensitivity.
Eryaspase demonstrated promising results in ALL patients
CEO Gil Beyen said, “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. We believe that the FDA’s Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.”
For numerous years, asparaginase has been an important part of ALL treatment. However, it has been linked to treatment-limiting hypersensitivity in around 30% of patients. In addition, the discontinuation of asparaginase medication has been linked to a worse event-free survival rate in ALL patients, underscoring the need for more asparaginase-based treatment alternatives.
The Nordic Society of Pediatric Hematology and Oncology presented positive results from a Phase 2 study evaluating enzyme activity and safety of eryaspase in pediatric ALL patients experiencing hypersensitivity reactions related to pegylated asparaginase at the American Society of Hematology annual meeting in December 2020. This study found that eryaspase, given in conjunction with chemotherapy every two weeks, provided a stable level of asparaginase enzyme activity and was generally well tolerated, with minimal hypersensitivity events.
ERYTECH Pharma to file BLA for eryaspase in Q4
The company previously stated that it plans to file a Biologics License Application (BLA) for eryaspase for the indication in Q4 2021, pending completion of the remaining processes.
Fast Track is a designation that expedites the review and development of a new treatment, either combined with other therapies or alone, to treat serious or life-threatening illnesses. There is evidence of the potential to meet an unmet medical need. The goal is to get innovative treatments for people who need them sooner.