trastuzumab

Ligand id: 5082

Name: trastuzumab

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Classification
Compound class Antibody
Approved drug? Yes (FDA (1998), EMA (2000))
International Nonproprietary Names
INN number INN
7637 trastuzumab
Synonyms
D5v8 | Herceptin® | R-597
Database Links
Specialist databases
IMGT/mAb-DB 97
Other databases
GtoPdb PubChem SID 178101775
PubChem SID 178101775
Search PubMed clinical trials trastuzumab
Search PubMed titles trastuzumab
Search PubMed titles/abstracts trastuzumab
Wikipedia Trastuzumab
Comments
Trastuzumab is a humanized IgG1κ monoclonal antibody targeting HER2.
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.

Biosimilars:
Mylan laboratories Inc. and Biocon Limited are partnering the marketing of MYL-1401O (trastuzumab-dkst, Hertraz®, Canmab®) a biosimilar initially approved in India. The FDA approved trastuzumab-dkst with the trade name Ogivri® in December 2017. Mylan withdrew its application for EMA marketing authorisation in August 2017.
Herzum® (CT-P6; Celltrion Inc.) is approved in Korea. CT-P6 as Credima® is pre-registered with the EMA.
SB3 (Ontruzant®, Samsung Bioepis) was approved by the EMA in November 2017 [1].
Amgen have trastuzumab-beta (ABP-980 [3]) in Phase 3 clinical trials for breast and gastro/esophageal cancers, and Phase 1 & 2 trials for other solid tumour types.
HLX02 (Shanghai Henlius Biotech) is being evaluated in direct comparison to the originator product Herceptin® in Phase 3 breast cancer clinical trial NCT03084237.
Pfizer's PF-05280014 is also in Phase 3 development- see their REFLECTIONS B327-02 trial NCT01989676 for example.