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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
Click on the PDF icon at the top of this introduction to read the full article.
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
Click on the PDF icon at the top of this introduction to read the full article.
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
Click on the PDF icon at the top of this introduction to read the full article.