Mosunetuzumab - Genentech
Alternative Names: Anti-CD20/CD3 T-cell dependent bispecific antibody; BTCT 4465A; CD20-TBD; CD20xCD3 T-cell engaging bispecific antibody; Lunsumio; Lunsumio VELO; mosunetuzumab-axgb; RG7828; RO7030816Latest Information Update: 27 Aug 2026
At a glance
- Originator Genentech
- Developer Chugai Pharmaceutical; Genentech; Roche
- Class Antineoplastics; Bispecific antibodies; Immunotherapies
- Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants
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Orphan Drug Status
Yes - Follicular lymphoma
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Follicular lymphoma
- Registered Non-Hodgkin's lymphoma
- Preregistration Diffuse large B cell lymphoma
- Phase II Marginal zone B-cell lymphoma; Systemic lupus erythematosus
- Phase I/II Chronic lymphocytic leukaemia
- No development reported B-cell lymphoma
Most Recent Events
- 05 Aug 2026 Roche plans to submit regulatory application in Systemic lupus erythematosus in 2029 or beyond (Roche pipeline, August 2026)
- 18 Jun 2026 US FDA assigns PDUFA action date of (09/02/2027) for Mosunetuzumab for Diffuse large B cell lymphoma (Second-line therapy or greater, Combination therapy) (SC)
- 18 Jun 2026 US FDA accepts sBLA for Mosunetuzumab for Diffuse large B cell lymphoma (Second-line therapy or greater, Combination therapy) for review in USA (SC)