← FDA DRUG APPROVALS

FDA BLA · BLA761263

LUNSUMIO

mosunetuzumab

Sponsor: GENENTECH INC

APPLICATION
BLA761263
TYPE
BLA
ORIGINAL APPROVAL
2022-12-22
LATEST ACTION
2026-06-18
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LUNSUMIO VELOPrescription
MOSUNETUZUMAB-AXGB 5MG/0.5ML · INJECTABLE · INJECTION
LUNSUMIOPrescription
MOSUNETUZUMAB-AXGB 1MG/ML · INJECTABLE · INJECTION
LUNSUMIO VELOPrescription
MOSUNETUZUMAB-AXGB 45MG/ML · INJECTABLE · INJECTION
LUNSUMIOPrescription
MOSUNETUZUMAB-AXGB 30MG/30ML · INJECTABLE · INJECTION

Approval history

2026-06-18Labeling · Supplement 10 · standard — Letter ↗AP
2025-12-19Efficacy · Supplement 6 · standard — Letter ↗AP
2024-11-22Efficacy · Supplement 5 · standard — Label ↗AP
2022-12-22Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →