FDA Approves Orphan Drug Erwinaze against Acute Lymphoblastic Leukemia
The approval is based on the results of clinical studies in 630 acute lymphoblastic leukemia patients.
The US FDA has approved EUSA Pharma's orphan drug ERWINAZE (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase.
ALL is the most common form of childhood cancer, with approximately 2,900 patients under the age of 20 diagnosed in the USA each year.
The ERWINAZE approval is based on the results of clinical studies in 630 ALL patients. In the pivotal efficacy study conducted in 58 subjects, 100% of evaluable patients achieved the asparaginase activity primary endpoint.
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