FDA grants fast track designation to eryaspase for hypersensitive ALL
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The FDA granted fast track designation to eryaspase for treatment of patients with acute lymphoblastic leukemia who developed hypersensitivity reactions to E. coli-derived pegylated asparaginase.
Asparaginase is a key component of ALL treatment; however, up to 30% of patients develop treatment-limiting hypersensitivity. Patients with ALL who discontinue asparaginase therapy can experience poorer EFS.
Eryaspase (Erytech Pharma) — which consists of L-asparaginase encapsulated inside donor-derived red blood cells — targets cancer cells’ altered asparagine and glutamine metabolism, according to an Erytech Pharma-issued press release.
A phase 2 trial evaluated the enzyme activity and safety of eryaspase primarily for pediatric patients with ALL who developed hypersensitivity reactions to pegylated asparaginase. Results showed eryaspase in combination with chemotherapy resulted in sustained asparaginase enzyme activity levels. The regimen also appeared well-tolerated, with few hypersensitivity reactions.
“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 biologics license application for eryaspase in hypersensitive ALL,” Gil Beyen, CEO of Erytech, said in the release. “We believe that the FDA’s fast track designation for eryaspase underscores its potential to address this high unmet medical need.”
Eryaspase also is under investigation for treatment of certain patients with pancreatic cancer or triple-negative breast cancer.
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