Pertuzumab Approved Naked monospecific

Antibody Information

Entry ID	2
INN	Pertuzumab
Status	Approved
Drug code(s)	2C4, R1273
Brand name	Perjeta
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	Non-small cell lung cancer, pancreatic, ovarian, breast, prostate, neuroendocrine 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)	June 27, 2003
Start of Phase 2	September 15, 2003
Start of Phase 3	September 15, 2006
Date BLA/NDA submitted to FDA	December 08, 2011
Year of first approval (global)	2012
Date of first US approval	June 08, 2012
INN, US product name	Pertuzumab
US or EU approved indications	Breast cancer (in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease; in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence)

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Genentech
Licensee/Partner	None
Comments about company or candidate	None
Full address of company	South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us