Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 76 |
| INN | Necitumumab |
| Status | Approved |
| Drug code(s) | IMC-11F8 |
| Brand name | Portrazza |
| 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) | EGFR |
| Indications of clinical studies | Non Small Cell Lung Cancer, Metastatic Colorectal Cancer, Solid Tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2004 |
| Start of Phase 2 | |
| Start of Phase 3 | November 15, 2009 |
| Date BLA/NDA submitted to FDA | December 02, 2014 |
| Year of first approval (global) | 2015 |
| Date of first US approval | November 24, 2015 |
| INN, US product name | Necitumumab |
| US or EU approved indications | Non-small cell lung cancer |
| Company | Eli Lilly and Company |
| Licensee/Partner | AstraZeneca, Shire |
| Comments about company or candidate | FDA advisory meeting held July 9, 2015; The FDA is expected to make a decision on Lilly's biologics license application for necitumumab later this year. Fast track designation for non-small cell lung cancer |
| Full address of company | Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |