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Erytech Pharma refiles application for blood cancer drug in Europe

Erytech Pharma SA resubmitted its application for Graspa with the European Medicine Agency to treat a type of blood cancer.

Graspa, also known as eryaspase, will be used to treat relapsed or refractory acute lymphoblastic leukemia, or ALL, a blood cancer affecting mainly the white blood cells.

The resubmission includes data from a phase 2/3 study in children and adults with ALL, along with additional data to address questions from the EMA's Committee for Medicinal Products for Human Use.

The clinical data showed that Graspa, in combination with chemotherapy, was more safe and effective than native L-asparaginase.

Erytech had withdrawn its original regulatory application in November 2016 to address the EMA's request for additional data.

The American Cancer Society estimates that about 5,970 new cases of ALL will be diagnosed in the U.S. in 2017, resulting in roughly 1,440 deaths. Erytech estimates that Europe records about the same number of ALL cases annually.