FDA granted priority review to the investigational bispecific T-cell engager antibody construct blinatumomab for the treatment of adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.\
Amgen, the drug’s sponsor, also submitted a marketing authorization application to the European Medicines Agency. The submissions include data from a phase II trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.
Blinatumomab, the first of Amgen’s investigational BiTE antibody constructs, has received orphan drug designation from the EMA and FDA, and breakthrough therapy and priority review designation from the FDA for the treatment of ALL.
Blinatumomab is designed to direct T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. Blinatumomab is also being investigated in pediatric relapsed/refractory ALL, relapsed/refractory Philadelphia positive B-precursor ALL, minimal residual disease positive B-precursor ALL, relapsed/refractory non-Hodgkin’s lymphoma, including relapsed/refractory diffuse large B-cell lymphoma.
