Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 74 |
| INN | Ibritumomab tiuxetan |
| Status | Approved |
| Drug code(s) | IDEC-Y2B8 |
| Brand name | Zevalin |
| mAb sequence source | mAb murine |
| General Molecular Category | Radioimmunotherapy, RIC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | Undisclosed |
| Discovery method/technology | Mouse origin |
| Target(s) | CD20 |
| Indications of clinical studies | Non-Hodgkin's B-cell lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 24, 1992 |
| Start of Phase 2 | May 20, 1998 |
| Start of Phase 3 | February 24, 1998 |
| Date BLA/NDA submitted to FDA | November 01, 2000 |
| Year of first approval (global) | 2002 |
| Date of first US approval | February 19, 2002 |
| INN, US product name | Ibritumomab tiuxetan |
| US or EU approved indications | Non-Hodgkin's lymphoma (relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma; previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy |
| Company | Biogen Idec |
| Licensee/Partner | Eli Lilly |
| Comments about company or candidate | None |
| Full address of company | 225 Binney Street, Cambridge, MA 02142, USA North America United States of America https://www.biogen.com/company/contact-us.html |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |