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LUNSUMIO (MOSUNETUZUMAB-AXGB)
LUNSUMIO (generic name: MOSUNETUZUMAB-AXGB) is a drug developed by GENENTECH INC. It is currently FDA-approved for Relapsed or refractory follicular lymphoma.
At a glance
| Generic name | MOSUNETUZUMAB-AXGB |
|---|---|
| Sponsor | GENENTECH INC |
| Target | B-lymphocyte antigen CD20 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Relapsed or refractory follicular lymphoma
Boxed warnings
- WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )
Common side effects
- CRS
- fatigue
- rash
- pyrexia
- headache
Key clinical trials
- A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) (Phase 1)
- Phase II Trial of Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma (EMZL) (ML44933) (Phase 2)
- A Phase Ib/II Study Evaluating the Safety and Efficacy of Mosunetuzumab in Combination With DA EPOCH in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas (Phase 1)
- Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma (Phase 3)
- A Phase II Trial Investigating MOsunetuzumab and ZAnubrutinib (BGB-3111) in Relapsed/refracTory Follicular Lymphoma Patients (MOZART) (Phase 2)
- A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (Phase 2)
- Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transfor (Phase 2)
- A Pilot Study of Subcutaneous Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for Untreated Indolent B-Cell Non-Hodgkin Lymphoma (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LUNSUMIO CI brief — competitive landscape report
- LUNSUMIO updates RSS · CI watch RSS
- GENENTECH INC portfolio CI
Frequently asked questions about LUNSUMIO
What is LUNSUMIO?
LUNSUMIO (MOSUNETUZUMAB-AXGB) is a pharmaceutical drug developed by GENENTECH INC, indicated for Relapsed or refractory follicular lymphoma.
What is LUNSUMIO used for?
LUNSUMIO is indicated for Relapsed or refractory follicular lymphoma.
Who makes LUNSUMIO?
LUNSUMIO is developed and marketed by GENENTECH INC (see full GENENTECH INC pipeline at /company/roche).
What is the generic name of LUNSUMIO?
MOSUNETUZUMAB-AXGB is the generic (nonproprietary) name of LUNSUMIO.
What development phase is LUNSUMIO in?
LUNSUMIO is FDA-approved (marketed).
What are the side effects of LUNSUMIO?
Common side effects of LUNSUMIO include CRS, fatigue, rash, pyrexia, headache.
What does LUNSUMIO target?
LUNSUMIO targets B-lymphocyte antigen CD20.
Related
- Target: All drugs targeting B-lymphocyte antigen CD20
- Manufacturer: GENENTECH INC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory follicular lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing