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- Donna Przepiorka
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Chia-Wen Ko
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Albert Deisseroth
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Carolyn L. Yancey
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Reyes Candau-Chacon
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Haw-Jyh Chiu
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Brenda J. Gehrke
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Candace Gomez-Broughton
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Robert C. Kane
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Susan Kirshner
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Nitin Mehrotra
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Tiffany K. Ricks
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Deborah Schmiel
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Pengfei Song
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Ping Zhao
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Qing Zhou
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Ann T. Farrell
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
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- Richard Pazdur
- Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
書誌事項
- 公開日
- 2015-09-14
- DOI
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- 10.1158/1078-0432.ccr-15-0612
- 公開者
- American Association for Cancer Research (AACR)
この論文をさがす
説明
<jats:title>Abstract</jats:title> <jats:p>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. Clin Cancer Res; 21(18); 4035–9. ©2015 AACR.</jats:p>
収録刊行物
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- Clinical Cancer Research
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Clinical Cancer Research 21 (18), 4035-4039, 2015-09-14
American Association for Cancer Research (AACR)