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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.

Background

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

FDA Approved Products

Lunsumio
Manufacturer:Genentech, Inc.
Route:INTRAVENOUS
Strength:30 mg in 30 mL
Approved: 2022/12/22
NDC:50242-142
Lunsumio
Manufacturer:Genentech, Inc.
Route:INTRAVENOUS
Strength:1 mg in 1 mL
Approved: 2022/12/22
NDC:50242-159

Singapore Approved Products

LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML
Manufacturer:Genentech, Inc.
Form:INFUSION, SOLUTION CONCENTRATE
Strength:1 mg/ml
Online:Yes
Approved: 2024/05/08
Approval:SIN17001P
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/30ML
Manufacturer:Genentech, Inc.
Form:INFUSION, SOLUTION CONCENTRATE
Strength:30 mg/30 ml
Online:Yes
Approved: 2024/05/08
Approval:SIN17002P

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