FDA Approval: Blinatumomab

Donna Przepiorka(Center for Drug Evaluation and Research), Chia‐Wen Ko(Center for Drug Evaluation and Research), Albert Deisseroth(Center for Drug Evaluation and Research), Carolyn L. Yancey(Center for Drug Evaluation and Research), Reyes Candau-Chacon(Center for Drug Evaluation and Research), Haw-Jyh Chiu(Center for Drug Evaluation and Research), Brenda J. Gehrke(Center for Drug Evaluation and Research), Candace Gomez-Broughton(Center for Drug Evaluation and Research), Robert C. Kane(Center for Drug Evaluation and Research), Susan Kirshner(Center for Drug Evaluation and Research), Nitin Mehrotra(Center for Drug Evaluation and Research), Tiffany K. Ricks(Center for Drug Evaluation and Research), Deborah H. Schmiel(Center for Drug Evaluation and Research), Pengfei Song(Center for Drug Evaluation and Research), Ping Zhao(Center for Drug Evaluation and Research), Qing Zhou(Center for Drug Evaluation and Research), Ann T. Farrell(Center for Drug Evaluation and Research), Richard Pazdur(Center for Drug Evaluation and Research)
Clinical Cancer Research
September 14, 2015
10.1158/1078-0432.ccr-15-0612
Cited by 360

Abstract

On December 3, 2014, the FDA granted accelerated approval of blinatumomab (Blincyto; Amgen, Inc.) for treatment of Philadelphia chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukemia (R/R ALL). Blinatumomab is a recombinant murine protein that acts as a bispecific CD19-directed CD3 T-cell engager. The basis for the approval was a single-arm trial with 185 evaluable adults with R/R ALL. The complete remission (CR) rate was 32% [95% confidence interval (CI), 26%-40%], and the median duration of response was 6.7 months. A minimal residual disease response was achieved by 31% (95% CI, 25%-39%) of all patients. Cytokine release syndrome and neurologic events were serious toxicities that occurred. Other common (>20%) adverse reactions were pyrexia, headache, edema, febrile neutropenia, nausea, tremor, and rash. Neutropenia, thrombocytopenia, and elevated transaminases were the most common (>10%) laboratory abnormalities related to blinatumomab. A randomized trial is required in order to confirm clinical benefit.

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