Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3.
Journal
Targeted oncology
ISSN: 1776-260X
Titre abrégé: Target Oncol
Pays: France
ID NLM: 101270595
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
pubmed:
5
8
2020
medline:
25
2
2023
entrez:
5
8
2020
Statut:
ppublish
Résumé
SB3 is a biosimilar of trastuzumab that has been approved for use in the treatment of human epidermal growth factor 2-positive breast cancer and human epidermal growth factor 2-positive gastric cancer. Antibody-dependent cellular cytotoxicity is one of several critical quality attributes of trastuzumab. Data from the development of SB3 support the hypothesis of a relationship between antibody-dependent cellular cytotoxicity activity and clinical outcomes in terms of the response rate and long-term survival. Current analytic methods utilizing advanced technology allow the detection of small changes in other quality attributes that influence antibody-dependent cellular cytotoxicity, such as glycosylation and FcγRIIIa binding. Use of such methods to monitor batch-to-batch consistency enables production of trastuzumab biosimilars with consistent quality. Trastuzumab biosimilars such as SB3 therefore have the potential to increase accessibility to trastuzumab-based therapy without compromising efficacy or safety.
Identifiants
pubmed: 32748046
doi: 10.1007/s11523-020-00742-w
pii: 10.1007/s11523-020-00742-w
pmc: PMC7560928
doi:
Substances chimiques
Trastuzumab
P188ANX8CK
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
467-475Commentaires et corrections
Type : ErratumIn
Références
Eur J Cancer. 2016 Jul;62:62-75
pubmed: 27208905
Clin Ther. 2016 Jul;38(7):1665-1673.e3
pubmed: 27368117
N Engl J Med. 2018 Aug 16;379(7):694-695
pubmed: 30110587
Lancet Oncol. 2018 Jul;19(7):861-863
pubmed: 29880293
Lancet. 2017 Jun 17;389(10087):2415-2429
pubmed: 27939064
Lancet Oncol. 2018 Jul;19(7):987-998
pubmed: 29880292
N Engl J Med. 2007 Jul 5;357(1):39-51
pubmed: 17611206
Curr Med Res Opin. 2016 May;32(5):829-34
pubmed: 26808864
MAbs. 2017 May/Jun;9(4):704-714
pubmed: 28296619
Ann Oncol. 2018 Aug 1;29(8):1634-1657
pubmed: 30032243
Clin Exp Rheumatol. 2016 Jul-Aug;34(4):698-705
pubmed: 27383278
BioDrugs. 2019 Aug;33(4):411-422
pubmed: 31190280
Breast Care (Basel). 2018 Jul;13(3):196-208
pubmed: 30069181
J Natl Compr Canc Netw. 2011 Sep;9 Suppl 4:S1-22
pubmed: 21976013
Nat Med. 2000 Apr;6(4):443-6
pubmed: 10742152
BioDrugs. 2020 Jun;34(3):363-379
pubmed: 32072477
BMC Cancer. 2015 Aug 18;15:591
pubmed: 26283654
Br J Cancer. 2018 Aug;119(3):263-265
pubmed: 30002436
Trends Biotechnol. 2009 Sep;27(9):546-53
pubmed: 19647883
Curr Oncol. 2018 Jun;25(Suppl 1):S171-S179
pubmed: 29910660
ESMO Open. 2017 Jan 16;1(6):e000142
pubmed: 28848668
Breast. 2017 Apr;32:199-216
pubmed: 28236776
J Clin Oncol. 2020 Apr 1;38(10):1070-1080
pubmed: 32058846
Nat Biotechnol. 2011 Apr;29(4):310-2
pubmed: 21478841
BioDrugs. 2014 Aug;28(4):363-72
pubmed: 24567263
J Clin Oncol. 2018 Apr 20;36(12):1260-1265
pubmed: 29443651
Biotechnol Bioeng. 2017 Dec;114(12):2696-2705
pubmed: 28842986
J Clin Oncol. 2018 Sep 10;36(26):2736-2740
pubmed: 29939838
Pharmaceuticals (Basel). 2014 Sep 17;7(9):943-53
pubmed: 25232798
J Clin Oncol. 2018 Aug 10;36(23):2433-2443
pubmed: 29787356
Br J Cancer. 2019 Jul;121(3):199-210
pubmed: 31257362
Lancet. 2014 Jul 12;384(9938):164-72
pubmed: 24529560
Eur J Cancer. 2019 Oct;120:1-9
pubmed: 31445454
Target Oncol. 2019 Dec;14(6):647-656
pubmed: 31620980
Ann Oncol. 2019 Aug 1;30(8):1194-1220
pubmed: 31161190
Future Oncol. 2015;11(1):61-71
pubmed: 25163910
Anticancer Drugs. 2015 Nov;26(10):1009-16
pubmed: 26352219
J Clin Oncol. 2018 Apr 1;36(10):968-974
pubmed: 29373094
Eur J Cancer. 2018 Apr;93:19-27
pubmed: 29448072