Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2 |
| INN | Pertuzumab |
| Status | Approved |
| Drug code(s) | 2C4, R1273 |
| Brand name | Perjeta |
| 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 | Non-small cell lung cancer, pancreatic, ovarian, breast, prostate, neuroendocrine 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) | June 27, 2003 |
| Start of Phase 2 | September 15, 2003 |
| Start of Phase 3 | September 15, 2006 |
| Date BLA/NDA submitted to FDA | December 08, 2011 |
| Year of first approval (global) | 2012 |
| Date of first US approval | June 08, 2012 |
| INN, US product name | Pertuzumab |
| US or EU approved indications | Breast cancer (in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease; in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence) |
| Company | Genentech |
| Licensee/Partner | None |
| 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 |