Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| 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 |
| 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 |
| 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 |
VEGF binds to VEGFR-2 (KDR); produced in NS0
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |