publication date: Dec. 5, 2014
Accelerated Approval Granted for Blincyto in R/R ALL
FDA granted accelerated approval for Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The approval was based on the achievement of durable complete remission and response with a reduction in minimal residual disease to less than 10-4 in a multicenter single-arm trial (Protocol MT103-211) that enrolled 185 patients with R/R ALL. Blinatumomab was administered by continuous infusion for 4 weeks of a 6-week cycle. Up to two cycles were used for induction and three cycles for consolidation.
In Protocol MT103-211, 32 percent (95% CI, 26% – 40%) of patients with R/R ALL attained CR with two cycles of treatment with single-agent blinatumomab, and the response was durable (median 6.7 months; range, 0.46 to 16.5 months). Furthermore, 31 percent (95% CI, 25%-39%) of the patients in the study had a CR with or without complete hematological recovery but with reduction in MRD to <10-4.
Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that activates endogenous T cells when bound to the CD19-expressing target cell. Activation of the immune system results in release of inflammatory cytokines. Cytokine release syndrome, including life-threatening or fatal events, was reported in 11 percent of the patients.
A Boxed Warning regarding cytokine release syndrome and neurological toxicities is provided in the product labeling. In addition, FDA approved blinatumomab with a Risk Evaluation and Mitigation Strategy. Blinatumomab is sponsored by Amgen Inc.
The Broad Institute, Harvard University, the Massachusetts Institute of Technology and Editas Medicine entered into a worldwide license agreement to grant Editas access to intellectual property related to the the CRISPR-Cas9 system genome … Continue reading 40-45 Drugs and Targets
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