Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 39 |
| INN | Relatlimab |
| Status | Approved |
| Drug code(s) | BMS-986016, ONO-4482 |
| Brand name | Opdualag (relatlimab + nivolumab combo) |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | LAG-3 |
| Indications of clinical studies | Multiple myeloma, melanoma, gastric cancer, colorectal cancer, glioblastoma, non-small cell lung cancer, solid tumors, Chronic lymphocytic leukemia and lymphomas |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2013 |
| Start of Phase 2 | May 15, 2016 |
| Start of Phase 3 | April 10, 2018 |
| Date BLA/NDA submitted to FDA | July 19, 2021 |
| Year of first approval (global) | 2022 |
| Date of first US approval | March 18, 2022 |
| INN, US product name | Relatlimab, relatlimab-rmbw |
| US or EU approved indications | Fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the FDA and EMA for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma |
| Company | Bristol-Myers Squibb |
| Licensee/Partner | Ono |
| Comments about company or candidate | Approved in EU on Sep 15, 2022 Sep 20, 2021: Bristol Myers Squibb announced that FDA has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022. NCT03470922 Phase 2/3 in melanoma started recruiting in April 2018 still recruiting as of last update in Sep 2020. NCT04150965 Phase 1/2 in MM not yet recruiting as of Nov 5, 2019. Nine Phase 2 studies sponsored by BMS recruiting as of Aug 2019. NCT02061761 Phase 1 study in NHL, CLL, HL started in Feb 2014. BMS has joint development/commercialization deal with Ono Phase 1 NCT01968109 as monotherapy or combination therapy with nivolumab started in Oct 2013. |
| 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. Combination of Relatlimab + Nivolumab is BMS-986213
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |