Obinutuzumab Approved Naked monospecific

Antibody Information

Entry ID	136
INN	Obinutuzumab
Status	Approved
Drug code(s)	RO5072759, GA101, RG7159
Brand name	Gazyva
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)	CD20
Indications of clinical studies	Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma
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)	September 15, 2007
Start of Phase 2
Start of Phase 3	December 21, 2009
Date BLA/NDA submitted to FDA	April 22, 2013
Year of first approval (global)	2013
Date of first US approval	November 01, 2013
INN, US product name	Obinutuzumab
US or EU approved indications	Chronic Lymphocytic Leukemia /Small Cell Lymphocytic Lymphoma, Indolent Non-Hodgkin's Lymphoma; combination ibrutinib obinutuzumab approved by the FDA for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.

Description/comment

GlycoMab technology; increased effector function.
INN was formerly afutuzumab

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Genentech
Licensee/Partner	None
Comments about company or candidate	Approved in the US in 2013, EU in 2014 Breakthrough Therapy designation from FDA announced in May 2013; BLA submitted in May 2013; priority review; Approved November 1, 2013. NCT01010061 Phase 3 started in Dec 2009. NCT00517530 Phase 1 started in Sep 2007.
Full address of company	South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us