The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).1 Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.2
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