Mosunetuzumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Mosunetuzumab
- lunsumio
- Lunsumio
- btct 4465a
- BTCT-4465A
- btct4465a
- BTCT4465A
- BTCT4465A (Mosunetuzumab) IV
- BTCT4465A (Mosunetuzumab) SC
- btct4465a mosunetuzumab iv
- mosunetuzumab
- Mosunetuzumab
- Mosunetuzumab (Cohorts A-C)
- Mosunetuzumab (Cohorts D-E)
- mosunetuzumab [INN]
- Mosunetuzumab [MI]
- MOSUNETUZUMAB [USAN]
- Mosunetuzumab [WHO-DD]
- mosunetuzumab axgb
- Mosunetuzumab axgb
- Mosunetuzumab axgb [WHO-DD]
- mosunetuzumab axgb who dd
- mosunetuzumab inn
- mosunetuzumab mi
- mosunetuzumab usan
- mosunetuzumab who dd
- Mosunetuzumab-axgb
- rg 7828
And 9 more, listed on the interactive page.
- ATC classification codes
- L01FX25
Sources for recorded values
- CAS registry numbers
- 1905409-39-3
- ChEMBL ID
- CHEMBL4297788
- FDA ingredient codes (UNII)
- LDJ89SS0YG
- 2625122
- 2625125
- Applicant
- GENENTECH INC
- Approval date
- 22 Dec 2022
- Application number
- BLA761263
- Status
- Authorised
- Status date
- 3 Jun 2022
- Authorisation date
- 3 Jun 2022
- Approved indications
- Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
- Product number
- EMEA/H/C/005680
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- Yes
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lymphoma, Follicular
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 7 Jun 2032
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- mosunetuzumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Agonist
- Action type
- Agonist
- Target
- CD3e
- Gene symbol
- CD3E
- Protein identifier
- P07766
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD20
- Protein identifier
- P11836
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P04234
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P07766
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P09693
- Action
- Binding
- Action type
- Binding
- Target
- CD20 (membrane-spanning 4-domains, subfamily A, member 1)
- Gene symbol
- MS4A1
- Protein identifier
- P11836
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD20
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING AGENT
- Target
- T cell surface glycoprotein CD3
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000094
- Subject identifier
- D015456
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000191
- Subject identifier
- D018442
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000630
- Subject identifier
- D018442
- Condition
- Lymphoma, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001938
- Subject identifier
- D016393
- Condition
- Hematologic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0002334
- Subject identifier
- D019337
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition identifier
- EFO_0000094
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0005952
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002083
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002334
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005556
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0007243
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0007915
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0015759
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0017604
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0018876
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0018906
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018908
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019462
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0019465
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0044889
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0100280
- Highest recorded phase
- 2
Warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Country
- United States
- Event
- covid-19
- Reports
- 6
- Reporting signal score
- 12.1449
- Event
- cytokine release syndrome
- Reports
- 26
- Reporting signal score
- 132.525
- Event
- disease progression
- Reports
- 16
- Reporting signal score
- 37.6049
- Event
- follicular lymphoma
- Reports
- 2
- Reporting signal score
- 11.8864
- Event
- hypogammaglobulinaemia
- Reports
- 3
- Reporting signal score
- 9.85264
- Event
- immune effector cell-associated neurotoxicity syndrome
- Reports
- 2
- Reporting signal score
- 8.59032
- Event
- infusion related reaction
- Reports
- 6
- Reporting signal score
- 10.2449
- Event
- neutropenia
- Reports
- 12
- Reporting signal score
- 18.5719
- Event
- oral fungal infection
- Reports
- 2
- Reporting signal score
- 8.03152
- Event
- pneumonitis
- Reports
- 4
- Reporting signal score
- 8.53109
- NCT02500407
- NCT05091424
- NCT03671018
- NCT03677141
- NCT04313608
- NCT04970901
- NCT03677154
- NCT04889716
- NCT04246086
- NCT04712097
- NCT04792502
- NCT05169658
- NCT05389293
- NCT05410418
- NCT05849857
- NCT05994235
- NCT06284122
- NCT06337318
- NCT06453044
- NCT05169515
- NCT05171647
- NCT05207670
- NCT05260957
- NCT05961696
- Dose
- 1 mg
- Route
- Intravenous
- How often
- Every 3 weeks
Conditions of use
- Administer over a minimum of 4 hours
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Disulfide bridge location
- Sequence
- 22-96 $ 22''-96'' $ 23'-94' $ 23'''-87''' $ 133'''-193''' $ 139'-199' $ 146-202 $ 149''-205'' $ 219'-222 $ 213'''-225'' $ 228-231'' $ 231-234'' $ 263-323 $ 266''-326'' $ 369-427 $ 372''-430''
- Component
- Sequence: Anti Homo sapiens CD3E Heavy chain
- Type
- Protein
- Sequence
- EVQLVQSGAEVKKPGASVKVSCKASGYTFTNYYIHWVRQAPGQGLEWIGWIYPGDGNTKYNEKFKGRATLTADTSTSTAYLELSSLRSEDTAVYYCARDSYSNYYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYGSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLSCAVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLVSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-96'' $ 23'-94' $ 23'''-87''' $ 133'''-193''' $ 139'-199' $ 146-202 $ 149''-205'' $ 219'-222 $ 213'''-225'' $ 228-231'' $ 231-234'' $ 263-323 $ 266''-326'' $ 369-427 $ 372''-430''
- Component
- Sequence: Anti Homo sapiens CD20 Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCRASSSVSYMHWYQQKPGKAPKPLIYAPSNLASGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQWSFNPPTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Sequence: Anti Homo sapiens CD20 Heavy chain
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGYTFTSYNMHWVRQAPGKGLEWVGAIYPGNGDTSYNQKFKGRFTISVDKSKNTLYLQMNSLRAEDTAVYYCARVVYYSNSYWYFDVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYGSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLWCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain: (anti-CD3E)
- Type
- Protein
- Sequence
- DIVMTQSPDSLAVSLGERATINCKSSQSLLNSRTRKNYLAWYQQKPGQPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCTQSFILRTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 50242-142
- 50242-159
- 50242-177
- 50242-201
Related records
Trials (55)
- A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL
- A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma
- A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
- A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
- A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
- A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
- A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma
- A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
- A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
- A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies
- A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma
- A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
- A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma
- A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.
- A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
- A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
- A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP
- A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
- A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
Approved for (3)
- Follicular lymphoma
- Neoplasm
- Neoplasm of mature B-cells
In development for (9)
- B-cell acute lymphoblastic leukemia Phase 1
- B-cell chronic lymphocytic leukemia Phase 1
- B-cell non-Hodgkin lymphoma Phase 1
- Diffuse large B-cell lymphoma Phase 2
- Hematopoietic and lymphoid system neoplasm Phase 1
- MALT lymphoma Phase 2
- Marginal zone lymphoma Phase 2
- Non-Hodgkin lymphoma Phase 3
- Richter transformation Phase 2