Entry ID | 133 |
INN | Bevacizumab |
Status | Approved |
Drug code(s) | RHU-MAB-VEGF |
Brand name | Avastin |
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 |
Target(s) | VEGF |
Indications of clinical studies | Renal Cell Carcinoma, colorectal, breast cancer |
Primary therapeutic area | Cancer |
Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | July 02, 1996 |
Start of Phase 2 | May 15, 1998 |
Start of Phase 3 | April 15, 2000 |
Date BLA/NDA submitted to FDA | September 30, 2003 |
Year of first approval (global) | 2004 |
Date of first US approval | February 26, 2004 |
INN, US product name | Bevacizumab |
US or EU approved indications | Non-Small Cell Lung Cancer, Renal Cell Cancer, Ovarian Cancer, Brain Cancer (Malignant Glioma; AA and GBM), Colorectal Cancer, Cervical Cancer, Breast Cancer; bevacizumab/carboplatin/paclitaxel treatment of stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection |
Company | Genentech |
Licensee/Partner | Bristol Myers Squibb, Merck |
Comments about company or candidate | None |
Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
None
Anticipated events | None |
Factor(s) contributing to discontinuation | None |