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

To access this members-only content, please log in.
Institutional subscribers, please log in with your IP.
If you're not a subscriber why not join today?
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2020 The Cancer Letter Inc.