Ibritumomab tiuxetan Approved Radioimmunotherapy, RIC

Antibody Information

Entry ID	74
INN	Ibritumomab tiuxetan
Status	Approved
Drug code(s)	IDEC-Y2B8
Brand name	Zevalin
mAb sequence source	mAb murine
General Molecular Category	Radioimmunotherapy, RIC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	Undisclosed
Discovery method/technology	Mouse origin

Therapeutic information

Target(s)	CD20
Indications of clinical studies	Non-Hodgkin's B-cell 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
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 24, 1992
Start of Phase 2	May 20, 1998
Start of Phase 3	February 24, 1998
Date BLA/NDA submitted to FDA	November 01, 2000
Year of first approval (global)	2002
Date of first US approval	February 19, 2002
INN, US product name	Ibritumomab tiuxetan
US or EU approved indications	Non-Hodgkin's lymphoma (relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma; previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Biogen Idec
Licensee/Partner	Eli Lilly
Comments about company or candidate	None
Full address of company	225 Binney Street, Cambridge, MA 02142, USA North America United States of America https://www.biogen.com/company/contact-us.html