Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Anti-CD20/CD3 T-cell dependent bispecific antibody, CD20/CD3 BiMAb, Mosunetuzumab (USAN/INN) + [14] |
Target |
Action inhibitors, stimulants |
Mechanism CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (03 Jun 2022), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (European Union), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States) |




| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Recurrent Follicular Lymphoma | United States | 22 Dec 2022 | |
| Refractory Follicular Lymphoma | United States | 22 Dec 2022 | |
| Follicular Lymphoma | European Union | 03 Jun 2022 | |
| Follicular Lymphoma | Iceland | 03 Jun 2022 | |
| Follicular Lymphoma | Liechtenstein | 03 Jun 2022 | |
| Follicular Lymphoma | Norway | 03 Jun 2022 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Aggressive B-Cell Non-Hodgkin Lymphoma | NDA/BLA | Canada | 01 Jun 2025 | |
| Large B-cell lymphoma | Phase 3 | Switzerland | 23 May 2023 | |
| B-cell lymphoma refractory | Phase 3 | United States | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | China | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Japan | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Argentina | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Brazil | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Canada | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Israel | 25 Apr 2022 | |
| B-cell lymphoma refractory | Phase 3 | Mexico | 25 Apr 2022 |
Phase 3 | - | 452 | sktyawmdrx(fbyieguvtb) = In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome and usage of tocilizumab occurred in less than 5% of patients. bxsfiatker (btojrndlxu ) | Positive | 20 Dec 2025 | ||
NCT03671018 (ASH2025) Manual | Phase 1/2 | B-cell lymphoma refractory Second line | 80 | vixuktjweu(lqxvvyhlkx) = otemeqxalo pwrdceuggo (yeayisxgqn, 61.6 - 89.2) View more | Positive | 06 Dec 2025 | |
vixuktjweu(lqxvvyhlkx) = viecdiojhc pwrdceuggo (yeayisxgqn, 33.8 - 66.2) View more | |||||||
Phase 2 | 42 | uipztrdfad(usyursbuaz) = jgzwprdvms otlsuezams (nkxmkegink ) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 52 | acvsbhflbv(uomcxwdpbj) = suljlgxgpj vvakonhwvw (jbcsrcohnd, 69 - 93) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 25 | Mosunetuzumab + Polatuzumab + Axicabtagene Ciloleucel | hcrbwzrdrb(hmhokriofe) = cwuuizrqqo ppklcbsqbt (gyuokvblkx ) View more | Positive | 06 Dec 2025 | ||
Phase 2 | Follicular Lymphoma First line | 101 | jvcwiicyam(lqdipulsdj) = jmzyyndfmi jxzlqclnuv (iyixctccgm, 83.8 - 96.1) View more | Positive | 06 Dec 2025 | ||
Phase 3 | 208 | Mosun-Pola | eyrabzptsw(unlydgpgwg) = Pts with Mosun-Pola had clinically meaningful improvements in mean scores by EORTC QLQ-C30 for constipation (C7, -10.2), while mean scores remained at baseline levels for pts in the R-GemOx arm. zlooafqbov (hdycfgctld ) View more | Positive | 06 Dec 2025 | ||
R-GemOx | |||||||
Phase 2 | 94 | wozchqmghw(sjvzlhxvaa) = n=1 frihclkvgb (kaawbxxlja ) View more | Positive | 06 Dec 2025 | |||
(pts with a CR) | |||||||
Phase 2 | 8 | efzzezxott(utppviyiva) = 1 patient received corticosteroids. 1 patient had a grade > 3 adverse event related to mosunetuzumab (2 episodes of grade 4 neutropenia, which responded to G-CSF and delay of mosunetuzumab) psvgtlymqc (ullfjmwlks ) | Positive | 06 Dec 2025 | |||
Phase 1 | 47 | tqdovymoie(klskitcjmd) = neutropenia (57% and 58%), injection site reactions (57%; all Gr 1/2 in Arm 1 only), CRS (Gr 1/2: 43% and 33%, no Gr ≥3), rash (Gr ≥3: 3% and 0%), and infections (Gr ≥3: 11% and 8%). mpuavypoka (cvdwsotzyd ) | Positive | 06 Dec 2025 | |||






