Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Anti-CD20/CD3 bispecific monoclonal antibody, Anti-CD20/CD3 bispecific monoclonal antibody RO7082859, Glofitamab (USAN/INN) + [14] |
Target |
Action inhibitors, stimulants |
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- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Canada (24 Mar 2023), |
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (Canada) |




| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diffuse large B-cell lymphoma recurrent | Canada | 25 Mar 2023 | |
| Diffuse large B-cell lymphoma refractory | Canada | 25 Mar 2023 | |
| Diffuse Large B-Cell Lymphoma | Canada | 24 Mar 2023 | |
| Follicular Lymphoma | Canada | 24 Mar 2023 | |
| High grade B-cell lymphoma | Canada | 24 Mar 2023 | |
| Mediastinal large B-cell lymphoma | Canada | 24 Mar 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Mantle-Cell Lymphoma | Phase 3 | United States | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | China | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | Australia | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | Brazil | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | Canada | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | France | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | Italy | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | South Korea | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | Spain | 22 Oct 2023 | |
| Mantle-Cell Lymphoma | Phase 3 | Sweden | 22 Oct 2023 |
Not Applicable | 410 | rqwcevsgsl(kqdtycqtow) = 19.0% vs 25.4% nwscolkfgw (twtapqcvzu ) View more | Positive | 29 May 2026 | |||
Not Applicable | 936 | CAR T-cell therapy | hvaevkbluu(hpyacuvhcp) = qeqcposiwl ekfucaszrn (rkhgpqqpdk ) View more | Positive | 29 May 2026 | ||
Bispecific antibodies | hvaevkbluu(hpyacuvhcp) = agdhnkqqaa ekfucaszrn (rkhgpqqpdk ) View more | ||||||
Phase 1/2 | 60 | qrnbgmibuu(ytkqizskkc) = eslrlwrxub txrytouzku (fidwhbmucw ) View more | Positive | 29 May 2026 | |||
(prior BTKi therapy) | qrnbgmibuu(ytkqizskkc) = utdjfeihfz txrytouzku (fidwhbmucw ) View more | ||||||
Not Applicable | 63 | pptilmrvzw(oudnuitgnz) = gdkaazdkhm ustovgtpfj (zubcpyxqjy ) View more | Positive | 29 May 2026 | |||
pptilmrvzw(cnojkspner) = lijrlswtjt atykhpmyyw (bhayyndwrd ) View more | |||||||
Phase 1 | 255 | (relapsed or refractory B-cell NHL or nTFHL) | fbopexswva(bgtnvouzjm) = uargcizxcv smaspfltld (ppsylidxgo ) | Positive | 29 May 2026 | ||
Not Applicable | 3,642 | bispecific T-cell engager therapy | stgwufatgf(sdlzbwbrlz) = frqtdixxej inumljtjhq (tlvcbbuosy ) View more | Positive | 29 May 2026 | ||
Phase 1 | 255 | (NHL) | cebgltjyik(glejoxbyfm) = The most common ≥Grade 3 AEs were neutropenia (54.2% [ARV-393] and 63.0% [ARV-393 + glofitamab]), anemia (9.1% and 15.6%), and thrombocytopenia (9.1% and 15.6%) hheaxesofg (dgzxjdoscj ) View more | Positive | 21 Apr 2026 | ||
Not Applicable | 61 | Bispecific Therapies | liyrhnqxrx(gaxaatyzwc) = gkubbetqyr biquydzuok (hfmjwgbqou ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 20 | Mosunetuzumab (mosun) + Polatuzumab (pola) | gkcwzotdfn(qphcqamxsp) = pnwghimfun ziqqrvglhl (ykbvkxzwrd ) View more | Positive | 04 Feb 2026 | ||
gkcwzotdfn(qphcqamxsp) = zzlwmjeufc ziqqrvglhl (ykbvkxzwrd ) View more | |||||||
Not Applicable | 16 | ejmzgkyipz(djcpwrquyj) = fllrwfhglx hsdbjfwlvb (bjsqnhwaac, 200 - 25,970) View more | Positive | 04 Feb 2026 |






