FDA Approval: Blinatumomab

被引：245

作者：

Przepiorka, Donna ^{[1
]}

Ko, Chia-Wen ^{[1
]}

Deisseroth, Albert ^{[1
]}

Yancey, Carolyn L. ^{[1
]}

Candau-Chacon, Reyes ^{[1
]}

Chiu, Haw-Jyh ^{[1
]}

Gehrke, Brenda J. ^{[1
]}

Gomez-Broughton, Candace ^{[1
]}

Kane, Robert C. ^{[1
]}

Kirshner, Susan ^{[1
]}

Mehrotra, Nitin ^{[1
]}

Ricks, Tiffany K. ^{[1
]}

Schmiel, Deborah ^{[1
]}

Song, Pengfei ^{[1
]}

Zhao, Ping ^{[1
]}

Zhou, Qing ^{[1
]}

Farrell, Ann T. ^{[1
]}

Pazdur, Richard ^{[1
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

CLINICAL CANCER RESEARCH | 2015年 / 21卷 / 18期

关键词：

ACUTE LYMPHOBLASTIC-LEUKEMIA; ACUTE LYMPHOCYTIC-LEUKEMIA; STEM-CELL TRANSPLANTATION; MINIMAL RESIDUAL DISEASE; SALVAGE THERAPY; CHEMOTHERAPY; ADULTS;

D O I：

10.1158/1078-0432.CCR-15-0612

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C)2015 AACR.

引用

页码：4035 / 4039

页数：5

共 50 条

[1] Eliminating MRD — FDA approval of blinatumomab for B-ALL in complete remission
Talal Hilal
Vinay Prasad
[J]. Nature Reviews Clinical Oncology, 2018, 15 : 727 - 728
[2] HEALTH POLICY Eliminating MRD - FDA approval of blinatumomab for B-ALL in complete remission
Hilal, Talal
Prasad, Vinay
[J]. NATURE REVIEWS CLINICAL ONCOLOGY, 2018, 15 (12) : 727 - 728
[3] Blinatumomab: First Global Approval
Sanford, Mark
[J]. DRUGS, 2015, 75 (03) : 321 - 327
[4] Blinatumomab: First Global Approval
Mark Sanford
[J]. Drugs, 2015, 75 : 321 - 327
[5] FDA approval
不详
[J]. GERIATRICS, 2001, 56 (11) : 16 - 16
[6] FDA approval
不详
[J]. GERIATRICS, 2001, 56 (09) : 16 - 16
[7] FDA approval
不详
[J]. GERIATRICS, 2001, 56 (03) : 20 - 20
[8] FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia
Pulte, E. Dianne
Vallejo, Jonathon
Przepiorka, Donna
Nie, Lei
Farrell, Ann T.
Goldberg, Kirsten B.
McKee, Amy E.
Pazdur, Richard
[J]. ONCOLOGIST, 2018, 23 (11): : 1366 - 1371
[9] FDA approval for ACTIS
不详
[J]. MODERN PLASTICS, 2000, 77 (09): : 10 - 10
[10] Requirements for FDA Approval
Basu, Sankar
[J]. PROCEEDINGS OF LIGHT-ACTIVATED TISSUE REGENERATION AND THERAPY CONFERENCE, 2008, 12 : 269 - 269

← 1 2 3 4 5 →