Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 98 |
| INN | Ipilimumab |
| Status | Approved |
| Drug code(s) | MDX-010, MDX-101, 10D1, BMS-734016 |
| Brand name | Yervoy |
| 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 | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab) |
| Target(s) | CTLA-4 |
| Indications of clinical studies | Melanoma; lung, liver, brain, prostate, pancreatic, head & neck cancers |
| 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 06, 2000 |
| Start of Phase 2 | |
| Start of Phase 3 | September 27, 2004 |
| Date BLA/NDA submitted to FDA | June 25, 2010 |
| Year of first approval (global) | 2011 |
| Date of first US approval | March 25, 2011 |
| INN, US product name | Ipilimumab |
| US or EU approved indications | Melanoma ( Treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older); Adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy). In 2018, the combination of Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). |
| Company | Bristol-Myers Squibb |
| Licensee/Partner | None |
| Comments about company or candidate | NCT00094653 Phase 3 MDX-010-20 study started Sep 27, 2004. NCT00032045 Phase 2 started in Jan 2002. NCT00028431 Phase 1 study started in Aug 2001 sponsored by U of Southern California FDA summary review states that 3 INDs for clinical development were submitted in 2000 |
| Full address of company | Route 206 & Province Line Road Princeton, New Jersey 08543 North America United States of America https://www.bms.com/about-us/contact-us.html |
Immune checkpoint target
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |