FDA Approval: Blinatumomab

被引：246

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

[41] Challenges to the FDA approval of mifepristone
Calhoun, BC
Harrison, DJ
[J]. ANNALS OF PHARMACOTHERAPY, 2004, 38 (01) : 163 - 168
[42] Zelboraf Receives FDA Approval
不详
[J]. JOURNAL OF DRUGS IN DERMATOLOGY, 2011, 10 (10) : 1215 - 1215
[43] FDA approval is crucial to Vernalis
不详
[J]. CHEMISTRY IN BRITAIN, 2001, 37 (11) : 12 - 12
[44] FDA: Close to approval of taxotere
不详
[J]. ANNALS OF ONCOLOGY, 1995, 6 (10) : 958 - 958
[45] FDA approval for PET colours without FDA listing
[J]. 2000, MCM Publishing, London, Engl
[46] Next Up for FDA Approval: Fewer FDA Rules
Mukherjee, Sy
[J]. FORTUNE, 2017, 175 (05) : 14 - 14
[47] FDA DRUG APPROVAL PACKAGES IN RESEARCH You can now search FDA approval documents easily at fda.opentrials.net
Goldacre, Ben
Turner, Erick
[J]. BMJ-BRITISH MEDICAL JOURNAL, 2017, 356
[48] TREATMENT FOR IMPOTENCE GAINS FDA APPROVAL
不详
[J]. AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 1995, 52 (19) : 2078 - 2079
[49] GE salmon gains FDA approval
Cima, Greg
[J]. JAVMA-JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION, 2016, 248 (01): : 25 - 25
[50] GELLAN GUM RECEIVES FDA APPROVAL
不详
[J]. FOOD TECHNOLOGY, 1990, 44 (11) : 88 - 90

← 1 2 3 4 5 →