Is Mosunetuzumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Mosunetuzumab, including LUNSUMIO (Prescription); LUNSUMIO VELO (Prescription).

Is Mosunetuzumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mosunetuzumab: Lunsumio.

Are there safety signals or safety updates for Mosunetuzumab?

US FDA: 2 entries (latest 2026-06-18).

Active substance

Mosunetuzumab

US FDA 2
EMA 1
Health Canada 3
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LUNSUMIO	1MG/ML; 30MG/30ML	injectable · injection	GENENTECH INC	Prescription	22 Dec 2022
LUNSUMIO VELO	5MG/0.5ML; 45MG/ML	injectable · injection	GENENTECH INC	Prescription	22 Dec 2022

EMA European Union — centrally authorised medicines

Lunsumio Roche Registration GmbH · Authorised · authorised 3 Jun 2022 · ATC L01FX25

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LUNSUMIO	02565226	1 MG / ML	SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED
LUNSUMIO SC	02567369	5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED
LUNSUMIO SC	02567377	45 MG / ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 18 Jun 2026 LUNSUMIO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2026 LUNSUMIO VELO — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for mosunetuzumab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.