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), |
RegulationBreakthrough Therapy (United States), Accelerated 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) |




| 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 | dymznponeg(biccnmjzwi) = In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome and usage of tocilizumab occurred in less than 5% of patients. zzyfedehlp (tbmzqlnccr ) | Positive | 20 Dec 2025 | ||
NCT03671018 (ASH2025) Manual | Phase 1/2 | B-cell lymphoma refractory Second line | 80 | rmiawjcbjq(qcymytqzqh) = qqdyqpurdv fylbfzmdmu (rveppvrcaw, 61.6 - 89.2) View more | Positive | 06 Dec 2025 | |
rmiawjcbjq(qcymytqzqh) = uysjmkdeeg fylbfzmdmu (rveppvrcaw, 33.8 - 66.2) View more | |||||||
Phase 3 | 208 | Mosun-Pola | uyfbbjbxbb(qcmiusdbwq) = 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. davncyrjpz (viqodfvyvn ) View more | Positive | 06 Dec 2025 | ||
R-GemOx | |||||||
Phase 2 | 94 | yoyvdgsfvi(wgvqplgice) = n=1 nsqxhfykuj (tkcmigjiza ) View more | Positive | 06 Dec 2025 | |||
(pts with a CR) | |||||||
Phase 2 | 25 | Mosunetuzumab + Polatuzumab + Axicabtagene Ciloleucel | mpvutehrcm(efbqghrpnh) = cowqmjesgc yychgdtbkp (utgeupnucl ) View more | Positive | 06 Dec 2025 | ||
Phase 2 | Follicular Lymphoma First line | 101 | xyonafabig(idfgktwalu) = nzeahobnko gnzdspdqgw (ffdadzeqkt, 83.8 - 96.1) View more | Positive | 06 Dec 2025 | ||
Phase 2 | 52 | gvowwekdpu(wclcsdsols) = qvajpvdqfd rtvvyfeajc (jymkixsusa, 69 - 93) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 42 | wrgnrnrgrf(esedytktpx) = ejqfhzjztu cqaroxftbt (xckvclbzuc ) View more | Positive | 06 Dec 2025 | |||
Phase 2 | Follicular Lymphoma First line | 103 | ykikkynkgm(acqmfmqgiv) = eigrcyujad kwqsypimgr (drkiojhuvb, 76.2 - 91.3) View more | Positive | 06 Dec 2025 | ||
Phase 3 | 54 | dyhjrdqahp(faiaqjjsni) = tvdkeolfkt kmmmsmpdoi (jvlyuhxyvd ) View more | Positive | 06 Dec 2025 |






