Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 163 |
| INN | Trastuzumab |
| Status | Approved |
| Drug code(s) | None |
| Brand name | Herceptin |
| 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) | HER2 |
| Indications of clinical studies | Breast, ovarian 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) | April 21, 1992 |
| Start of Phase 2 | May 15, 1994 |
| Start of Phase 3 | June 15, 1995 |
| Date BLA/NDA submitted to FDA | May 04, 1998 |
| Year of first approval (global) | 1998 |
| Date of first US approval | September 25, 1998 |
| INN, US product name | Trastuzumab |
| US or EU approved indications | Breast cancer, Gastric cancer |
| Company | Genentech |
| Licensee/Partner | Novartis, Tanox |
| Comments about company or candidate | Feb 2019: US Food and Drug Administration has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease |
| 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 |