YAbS







Rituximab Approved Naked monospecific

Antibody Information

Entry ID 73
INN Rituximab
Status Approved
Drug code(s) IDEC-C2B8
Brand name Rituxan
mAb sequence source mAb chimeric
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 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, Australia
Status Active
Start of clinical phase (IND filing or first Phase 1) December 15, 1992
Start of Phase 2 November 15, 1993
Start of Phase 3 April 15, 1995
Date BLA/NDA submitted to FDA February 28, 1997
Year of first approval (global) 1997
Date of first US approval November 26, 1997
INN, US product name Rituximab
US or EU approved indications Non-Hodgkin’s Lymphoma and diffuse large B-cell lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies, Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids; moderate to severe pemphigus vulgaris; granulomatosis with polyangiitis and microscopic polyangiitis in children 2 years of age and older in combination with glucocorticoids . As of March 2019, MabThera is approved to treat four autoimmune diseases in the US and Europe.

Company information

Company Biogen Idec
Licensee/Partner Schering, Genentech
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

Description/comment

None

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None