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Blinatumomab Granted Full EU Approval for B-cell Precursor ALL

Jason M. Broderick @jasoncology
Published: Tuesday, Jun 19, 2018

David M. Reese, MD

David M. Reese, MD

The European Commission (EC) has granted blinatumomab (Blincyto) full marketing authorization for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL), according to Amgen, the developer of the anti-CD19 immunotherapy.

Grade ≥3 AEs of interest included neutropenia (38% in the blinatumomab arm vs 58% in the standard chemotherapy arm), infection (34% vs 52%), neurologic events (9% vs 8%), and cytokine release syndrome (5% vs 0).

References

  1. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376(9):836-847. doi:10.1056/NEJMoa1609783.
  2. Topp MS, Stein A, Nicola Gökbuget N, et al. Blinatumomab improved overall survival in patients with relapsed or refractory Philadelphia negative B-cell precursor acute lymphoblastic leukemia in a randomized, open-label phase 3 study (TOWER). Presented at: 2016 European Hematology Association Congress; June 9-12, 2016; Copenhagen, Denmark. Abstract S149.

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View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: 3rd Annual European Congress on Hematology™: Focus on Lymphoid MalignanciesNov 29, 20192.0
Advances in™ ALL: The Role of T-Cell Engaging Immunotherapy in Treating Relapsed DiseaseNov 30, 20191.0
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