Trastuzumab Approved Naked monospecific

Antibody Information

Entry ID	163
INN	Trastuzumab
Status	Approved
Drug code(s)	None
Brand name	Herceptin
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	HER2
Indications of clinical studies	Breast, ovarian Cancer
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved EU, US, Japan, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	April 21, 1992
Start of Phase 2	May 15, 1994
Start of Phase 3	June 15, 1995
Date BLA/NDA submitted to FDA	May 04, 1998
Year of first approval (global)	1998
Date of first US approval	September 25, 1998
INN, US product name	Trastuzumab
US or EU approved indications	Breast cancer, Gastric cancer

Company information

Company	Genentech
Licensee/Partner	Novartis, Tanox
Comments about company or candidate	Feb 2019: US Food and Drug Administration has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease
Full address of company	South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None