Drug Type Monoclonal antibody |
Synonyms Afutuzumab, Anti-CD20 monoclonal antibody R7159, Gazyvaro + [22] |
Target |
Mechanism CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (01 Nov 2013), |
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09321 | Obinutuzumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
CD20 Positive B-Cell Chronic Lymphocytic Leukemia | JP | 23 Dec 2022 | |
CD20 positive Follicular Lymphoma | JP | 02 Jul 2018 | |
CD20 positive Follicular Lymphoma | JP | 02 Jul 2018 | |
Follicular Lymphoma | AU | 15 May 2014 | |
Chronic Lymphocytic Leukemia | US | 01 Nov 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Marginal Zone B-Cell Lymphoma | NDA/BLA | CN | 28 Sep 2019 | |
Nephrosis, Congenital | Phase 3 | US | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | CN | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | JP | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | BE | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | BR | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | FR | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | IT | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | PL | 29 Mar 2023 | |
Nephrosis, Congenital | Phase 3 | ES | 29 Mar 2023 |
Phase 1/2 | 2 | uzllzavssf(lyshyrxqra) = kgwamrvnnr fnjczalnpr (lnoxvrvcae, meeredklnk - spbbuxjblt) View more | - | 16 May 2024 | |||
HCL-PG04 (EHA2024) Manual | Phase 2 | Hairy Cell Leukemia BRAF V600E | 26 | ehgnwjkzxm(jtkkycnrng) = nnkxnvksqz jyezxkvmbg (vuhmfzxqpa ) View more | Positive | 14 May 2024 | |
Not Applicable | 26 | Obinutuzumab + CHOP | pkhowzlhna(kejlekxiyq) = Most common side effects were hematologic and infectious vnqjblpjgr (sjjrvalvdn ) | Positive | 14 May 2024 | ||
Obinutuzumab + DA-EPOCH | |||||||
Not Applicable | Follicular Lymphoma First line | 301 | Obinutuzumab plus Bendamustine (GB) | dkiayjkxnt(watpgqrvzx) = no new safety signals were identified compared with the data from the GALLIUM study ueeiflgdmv (rxzybyqzhx ) View more | Positive | 14 May 2024 | |
Obinutuzumab plus Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (G-CHOP) | |||||||
Not Applicable | 34 | xnxpbdqvnd(aqmfhrzmto) = mwmszjukzz aspwnfssil (vrzpvhctve ) | Positive | 14 May 2024 | |||
Not Applicable | B-Cell Lymphoma Maintenance | 165 | fepqiqoyhi(jevsgyjdwb) = 42 (25%) xvawmybmwk (viqqqelyac ) View more | - | 11 Dec 2023 | ||
Phase 2 | 26 | xaynaacrdp(cfvcjrfcxd) = jbnydqtken cxzniuxbth (oaluwxxlhp ) View more | Positive | 11 Dec 2023 | |||
Phase 3 | 299 | gfmyqtdhoc(gpzeusgqfu) = tsmxkgpbpj lfqsspmeop (dvdbmigjsv ) View more | - | 11 Dec 2023 | |||
gfmyqtdhoc(gpzeusgqfu) = qejatoxchj lfqsspmeop (dvdbmigjsv ) View more | |||||||
Phase 2 | 10 | hmbcxnaoha(zqkvrmqnfp) = yhtjbwgyxy nkfncbynzz (vpoylznbkk ) View more | - | 11 Dec 2023 | |||
Phase 2 | 25 | aiblhvfeyz(zrocgjsavj) = The most common treatment-related AEs (≥20%) were predominantly low-grade and manageable, including diarrhea (52%), neutropenia (28%), infusion-related reaction (24%), bruising (20%), COVID-19 infection (20%), nausea (20%), thrombocytopenia (20%), and rash (20%). The grade 3 or higher treatment-related AEs were neutropenia (12%), infusion-related reaction (8%), COVID-19 (8%), diarrhea (4%), transaminitis (4%), thrombocytopenia without bleeding (4%), and rash (4%) mumfywhhxb (nrwqwfavtw ) View more | - | 11 Dec 2023 |