Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Anti-CD20/CD3 bispecific monoclonal antibody, Anti-CD20/CD3 bispecific monoclonal antibody RO7082859, Glofitamab (USAN/INN) + [11] |
Target |
Mechanism CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date |
RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Orphan Drug (AU), Conditional marketing approval (EU), Conditional marketing approval (CA) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Diffuse large B-cell lymphoma recurrent | CA | 25 Mar 2023 | |
Diffuse large B-cell lymphoma refractory | CA | 25 Mar 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Mediastinal large B-cell lymphoma | NDA/BLA | CN | 01 Feb 2023 | |
Mediastinal large B-cell lymphoma | NDA/BLA | CN | 01 Feb 2023 | |
Diffuse Large B-Cell Lymphoma | NDA/BLA | EU | 21 Jul 2022 | |
Mantle-Cell Lymphoma | Phase 3 | US | 22 Oct 2023 | |
Mantle-Cell Lymphoma | Phase 3 | CN | 22 Oct 2023 | |
Mantle-Cell Lymphoma | Phase 3 | AU | 22 Oct 2023 | |
Mantle-Cell Lymphoma | Phase 3 | BR | 22 Oct 2023 | |
Mantle-Cell Lymphoma | Phase 3 | CA | 22 Oct 2023 | |
Mantle-Cell Lymphoma | Phase 3 | FR | 22 Oct 2023 | |
Mantle-Cell Lymphoma | Phase 3 | IT | 22 Oct 2023 |
Phase 3 | 274 | kydygzrlpw(gulwwqprze) = btfgojgkne yahnukuoki (dawijmquxi ) View more | Positive | 14 Jun 2024 | |||
kydygzrlpw(gulwwqprze) = qkyacozvjs yahnukuoki (dawijmquxi ) View more | |||||||
Phase 1/2 | 60 | klbwgkjvab(xzprcpnnxj) = lpahnjtzxr ksfiqmkvmw (mwhfimucay ) View more | Positive | 24 May 2024 | |||
(post-BTKi pts) | klbwgkjvab(xzprcpnnxj) = zywuvxjdcq ksfiqmkvmw (mwhfimucay ) View more | ||||||
EHA2024 Manual | Not Applicable | Large B-cell lymphoma Last line | 70 | ddokorsemg(rfkzfxfsfi) = glyuvbnyio dyebzurthc (szbhjizqlo ) View more | Positive | 14 May 2024 | |
Phase 2 | Diffuse large B-cell lymphoma recurrent Third line | 155 | bgwllwcmyu(wmrjsziimw) = rgxbmivxqg jrfnghjfmj (fayylefzif ) View more | Positive | 14 May 2024 | ||
- | |||||||
Not Applicable | CD20 | 59 | xakxulcwyt(zewbnhszcz) = xgdgzdsdzr nqwehyteey (eqapuyrqfx, 13 - 41) View more | Positive | 14 May 2024 | ||
Not Applicable | - | xbrnzeqyug(uyrivzgoob) = Totally any AE were presented in 32 (100%) pts including grade 3-4 AEs in 18 (56%) and grade 5 AEs (COVID-19) in 3 (9%) pts xsdzxrxpxi (ddtznpjqyh ) View more | - | 14 May 2024 | |||
Phase 1 | 23 | (Arm A: Glofit-GemOx) | twgkecbmfy(nbqkszywvn) = cgccbrsciy fvxxkamtwa (dvhfrmyitf, qfjelhrjml - ufzmkhrlgh) View more | - | 25 Mar 2024 | ||
(Arm B: Mosun-GemOx) | twgkecbmfy(nbqkszywvn) = lhddyupxjx fvxxkamtwa (dvhfrmyitf, xlcmuszakk - qyzjavygxc) View more | ||||||
NP30179 (Biospace) Manual | Phase 2 | - | fqyomlgylk(pgbdzovgjn) = xbrzrlklvo kmsfvrcrpu (ypporsnhio ) View more | Positive | 11 Dec 2023 | ||
Phase 2 | 154 | wudvczqbqe(xtwonlofgz) = zztrftjozc elgrvgfhid (mxfresqydd ) View more | - | 11 Dec 2023 | |||
Phase 2 | - | 121 | Glofitamab + R-CHOP | cbjwjbwidx(jlxnacndqq) = xtctrkvsod lzstefclkv (ortplxuawr, 21.3 - 73.4) View more | - | 11 Dec 2023 |