ERYTECH's Graspa Gains FDA ODD For AML
ERYTECH Pharma's lead product Graspa (erythrocyte-encapsulated L-asparaginase; ERY-ASP) has been granted orphan drug designation (ODD) by the FDA for the treatment of acute myeloid leukaemia (AML).
Graspa is a new enzyme formulation of L-asparaginase, with a safer and broader range of clinical use than existing forms due to the entrapment and protection of the enzyme inside homologous red blood cells. ERY-ASP is in Phase III trial for acute lymphoblastic leukaemia (ALL) and in Phase IIb trial for AML in Europe. A Phase I study in adult ALL is being launched in the US, as well as a Phase II study in pancreatic cancer in Europe.