Mosunetuzumab
Drug Details
- Generic Name
- Mosunetuzumab
- Brand Names
- Lunsumio, Lunsumio Velo
- Application Number
- BLA761263
- Sponsor
- Genentech, Inc.
- NDC Codes
- 6
- Dosage Forms
- CONCENTRATE, LIQUID, INJECTION
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Active Ingredients
- MOSUNETUZUMAB
Indications and Usage
1 INDICATIONS AND USAGE LUNSUMIO VELO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO VELO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).