Necitumumab Approved Naked monospecific

Antibody Information

Entry ID	76
INN	Necitumumab
Status	Approved
Drug code(s)	IMC-11F8
Brand name	Portrazza
mAb sequence source	mAb human
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	Phage display-DYAX

Therapeutic information

Target(s)	EGFR
Indications of clinical studies	Non Small Cell Lung Cancer, Metastatic Colorectal Cancer, Solid Tumors
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
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 15, 2004
Start of Phase 2
Start of Phase 3	November 15, 2009
Date BLA/NDA submitted to FDA	December 02, 2014
Year of first approval (global)	2015
Date of first US approval	November 24, 2015
INN, US product name	Necitumumab
US or EU approved indications	Non-small cell lung cancer

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Eli Lilly and Company
Licensee/Partner	AstraZeneca, Shire
Comments about company or candidate	FDA advisory meeting held July 9, 2015; The FDA is expected to make a decision on Lilly's biologics license application for necitumumab later this year. Fast track designation for non-small cell lung cancer
Full address of company	Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us