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Full FDA Approval Sought for Blinatumomab in Acute Lymphoblastic Leukemia

Jason M. Broderick @jasoncology
Published: Tuesday, Feb 14, 2017

Dr. Sean E. Harper

Sean E. Harper, MD

A supplemental biologics license application (sBLA) has been submitted to the FDA for the full regulatory approval of blinatumomab (Blincyto) as a treatment for patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), according to the developer of the anti-CD19 immunotherapy, Amgen. 

According to Amgen, the BLINCYTO label includes a Boxed Warning regarding cytokine release syndrome and neurological toxicities.
Topp MS, Stein A, 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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