Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 142 |
| INN | Isatuximab |
| Status | Approved |
| Drug code(s) | SAR650984 |
| Brand name | Sarclisa |
| mAb sequence source | mAb chimeric |
| 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) | CD38 |
| Indications of clinical studies | Plasma cell myeloma, multiple myeloma, T-cell Type Acute Leukemia-Precursor T-lymphoblastic Lymphoma/Leukaemia, Hematological 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) | December 07, 2009 |
| Start of Phase 2 | |
| Start of Phase 3 | December 15, 2016 |
| Date BLA/NDA submitted to FDA | April 30, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | March 02, 2020 |
| INN, US product name | Isatuximab, isatuximab-irfc |
| US or EU approved indications | In combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; Sarclisa, or isatuximab-irfc, was approved by the FDA for use in combination with carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have undergone one to three previous lines of therapy |
| Company | AbbVie |
| Licensee/Partner | Sanofi |
| Comments about company or candidate | Feb. 12, 2024: AbbVie announced that it has completed its acquisition of ImmunoGen. FDA approved March 2, 2020. July 2019: FDA accepts the BLA and sets a PDUFA date of April 30, 2020. In the second quarter of 2019, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application and Sanofi filed a Biologics License Application with the U.S. Food and Drug Administration (FDA), both for use of isatuximab in combination with pom-dex for the treatment of certain patients with RRMM. Start of Phase 3 in 1st line Multiple Myeloma in SCT eligible patients expected in H1 2018. Sanofi signed a clinical collaboration agreement with Roche to explore the role of atezolizumab in combination with isatuximab in certain solid tumors, reflecting scientific evidence that checkpoint inhibition by CD38 may reverse resistance to PD-L1. May 2017: Sanofi granted a fully paid exclusive license to develop, manufacture, and commercialize this cancer candidate. NCT02990338 Phase 3 in MM started in Dec 2016. Listed in Sanofi pipeline dated Feb 2014; EU and US orphan designations for myeloma. NCT02283775 Phase 1 started in May 2015. December 7, 2009: IND 103217 for SAR650984 was submitted to FDA for the treatment of hematological malignancies expressing the CD38 antigen. FDA issued a Safe to Proceed letter on December 29, 2009 for study TED10893, titled "A Phase I dose escalation safety and pharmacokinetic study of multiple intravenous administrations of a humanized monoclonal antibody (SAR650984) against CD38 in patients with selected CD38+ hematological malignancies." |
| Full address of company | Waltham, Massachusetts, United States North America United States of America https://www.immunogen.com/ |
Preclinical data published in Leukemia. 2016 Feb;30(2):399-408. doi: 10.1038/leu.2015.240
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |