Ramucirumab Approved Naked monospecific

Antibody Information

Entry ID	75
INN	Ramucirumab
Status	Approved
Drug code(s)	IMC-1121B
Brand name	Cyramza
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)	VEGFR2
Indications of clinical studies	Gastric Cancer; Adenocarcinoma, Hepatocellular Carcinoma, breast cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, melanoma, Stomach Cancer; Esophageal Cancer, Carcinoma of Urinary Tract; Urethral Carcinoma; Carcinoma of Ureter; Carcinoma of Renal Pelvis
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)	December 15, 2004
Start of Phase 2
Start of Phase 3	August 15, 2008
Date BLA/NDA submitted to FDA	August 23, 2013
Year of first approval (global)	2014
Date of first US approval	April 21, 2014
INN, US product name	Ramucirumab
US or EU approved indications	Colorectal Cancer, Non-Small Cell Lung Cancer, Gastric Cancer, monotherapy for hepatocellular carcinoma in patients with alpha-fetoprotein levels of 400 nanograms per milliliter or higher who were previously treated with sorafenib

Description/comment

VEGF binds to VEGFR-2 (KDR); produced in NS0

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Eli Lilly and Company
Licensee/Partner	None
Comments about company or candidate	EMA positive opinion given on Sep 26, 2014. Fast track designation, Rolling BLA started in Q1 2013; priority review granted in Oct 2013. First US approval for advanced stomach cancer or gastroesophageal junction adenocarcinoma. Approved in US April 21, 2014
Full address of company	Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us