Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 93 |
| INN | Mogamulizumab |
| Status | Approved |
| Drug code(s) | KW-0761 |
| Brand name | Poteligeo; Poteligio |
| 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) | CCR4 |
| Indications of clinical studies | Adult T-Cell leukemia and lymphoma, Non-Small Cell Lung Cancer, Peripheral T-Cell Lymphoma, Cutaneous T-Cell Lymphoma |
| 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) | February 15, 2007 |
| Start of Phase 2 | May 15, 2009 |
| Start of Phase 3 | November 15, 2012 |
| Date BLA/NDA submitted to FDA | October 04, 2017 |
| Year of first approval (global) | 2012 |
| Date of first US approval | August 08, 2018 |
| INN, US product name | Mogamulizumab, mogamulizumab-kpkc |
| US or EU approved indications | Treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy; treatment of adult patients with MF or SS who have received at least one prior systemic therapy (EU) |
| Company | Biowa (Kyowa Hakko Kirin) |
| Licensee/Partner | Amgen |
| Comments about company or candidate | EU marketing authorization granted in Nov 2018. Approved in US on Aug 8, 2018. May 30, 2018: Kyowa Hakko Kirin Co., Ltd. announced today that it has been notified that the U.S. Food and Drug Administration (FDA) is extending its review of the Biologics License Application (BLA) for mogamulizumab for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) target action date has been extended to September 4, 2018. Nov 2017: BLA given priority review, with PDUFA date of June 4, 2018. Aug 2017: The FDA granted breakthrough therapy designation to mogamulizumab for the treatment of mycosis fungoides and Sézary syndrome Approved in Japan on March 30, 2012. |
| Full address of company | Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004 Asia Japan https://www.kyowakirin.com/overview/index.html |
GPCR target. Afucosylated
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |