MedPath

Mosunetuzumab

Generic Name
Mosunetuzumab
Brand Names
Lunsumio
Drug Type
Biotech
CAS Number
1905409-39-3
Unique Ingredient Identifier
LDJ89SS0YG

Overview

Mosunetuzumab is a humanized anti-CD20/CD3 bispecific antibody. It can recognize and bind two different targets simultaneously, CD20 on cancer B-cells and CD3 on T-cells, allowing it to redirect T-cell cytotoxic activity to cancer cells. The standard of care for patients with B-cell lymphoma includes an anti-CD20 monoclonal antibody, such as rituximab, in combination with chemotherapy. However, patients with certain types of B-cell lymphoma, such as follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or aggressive B-cell lymphoma, have a high probability of relapse or recurrence after treatment. Mosunetuzumab has the potential to circumvent resistance to rituximab in patients with follicular lymphoma, and unlike CAR-T therapies such as axicabtagene ciloleucel and tisagenlecleucel, it is an “off-the-shelf” alternative, readily available to patients. In June 2022, the European Medicines Agency approved mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) FL who have received at least two prior systemic therapies. In January 2023, the use of mosunetuzumab was approved by the FDA under accelerated approval based on response rate.

Indication

Mosunetuzumab 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.

Associated Conditions

  • Relapsed or Refractory Follicular Lymphoma

Research Report

Published: Jun 19, 2025

Mosunetuzumab: A Comprehensive Clinical and Scientific Review of a First-in-Class Bispecific T-Cell Engager for Relapsed/Refractory Follicular Lymphoma

Introduction to Mosunetuzumab: A Novel Bispecific T-Cell Engager in Follicular Lymphoma

The Unmet Need in Relapsed/Refractory Follicular Lymphoma (R/R FL)

Follicular lymphoma (FL) is the second most common subtype of non-Hodgkin lymphoma (NHL) and is generally characterized by an indolent, or slow-growing, clinical course.[1] While it is considered a treatable disease, it is typically incurable with standard therapeutic approaches. The natural history of FL involves a pattern of remission and relapse, where patients often respond well to initial treatments but subsequently experience disease recurrence.[3] With each successive line of therapy, the duration of response and progression-free survival tends to shorten, and the disease may become increasingly refractory to treatment.[3]

A significant unmet clinical need exists for patients with relapsed or refractory (R/R) FL who have progressed after two or more prior lines of systemic therapy. This patient population has often been exposed to, and may be refractory to, standard-of-care agents, including an anti-CD20 monoclonal antibody such as rituximab and an alkylating agent.[5] For these heavily pretreated individuals, therapeutic options are limited, and prognoses are often poor, underscoring the urgent need for novel agents with distinct mechanisms of action and durable efficacy.

Introducing Mosunetuzumab (Lunsumio): A First-in-Class Therapeutic

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/06
Not Applicable
Not yet recruiting
Inhye Ahn
2025/06/22
Phase 2
Not yet recruiting
2025/04/29
Phase 2
Not yet recruiting
2025/04/13
Phase 2
Recruiting
GELLC (Grupo Español de Leucemia Linfocítica Crónica)
2025/02/17
Phase 2
Not yet recruiting
Danielle Wallace
2024/10/10
Phase 1
Recruiting
2024/09/19
Phase 2
Not yet recruiting
2024/08/26
Phase 2
Recruiting
Izidore Lossos, MD
2024/08/20
Phase 2
Recruiting
2024/07/09
Phase 2
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Genentech, Inc.
50242-142
INTRAVENOUS
30 mg in 30 mL
12/22/2022
Genentech, Inc.
50242-159
INTRAVENOUS
1 mg in 1 mL
12/22/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
6/3/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
SIN17001P
INFUSION, SOLUTION CONCENTRATE
1 mg/ml
5/8/2024
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/30ML
SIN17002P
INFUSION, SOLUTION CONCENTRATE
30 mg/30 ml
5/8/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Mosunetuzumab Injection
国药准字SJ20240049
生物制品
注射剂
12/17/2024
Mosunetuzumab Injection
国药准字SJ20240048
生物制品
注射剂
12/17/2024

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/30ML
N/A
N/A
N/A
3/3/2023
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/1ML
N/A
N/A
N/A
3/3/2023

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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