Glofitamab

Bispecific CD20-directed CD3 T Cell Engager — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Glofitamab is a drug in the Bispecific CD20-directed CD3 T Cell Engager class catalogued in DrugCentral. It was first approved by the FDA in 2023. Its mechanism of action is classified as CD20-directed Antibody Interactions, CD3 Receptor Agonists and CD3-directed Antibody Interactions. DrugCentral lists 2 molecular targets, including MS4A1 and CD3E. Recorded indications include Relapsed or refractory diffuse large B-cell lymphoma.

• Drug class: Bispecific CD20-directed CD3 T Cell Engager.
• Mechanism of action: CD20-directed Antibody Interactions; CD3 Receptor Agonists; CD3-directed Antibody Interactions.
• Molecular targets: MS4A1 and CD3E (2 listed in DrugCentral).
• Indications: Relapsed or refractory diffuse large B-cell lymphoma.
• ATC code: L01FX28 (Other monoclonal antibodies and antibody drug conjugates).

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (1)

• Relapsed or refractory diffuse large B-cell lymphoma

Mechanism & targets

• Mechanism of action (MoA): CD20-directed Antibody Interactions; CD3 Receptor Agonists; CD3-directed Antibody Interactions; Cytochrome P450 Inhibitors
• Established pharmacologic class: Bispecific CD20-directed CD3 T Cell Engager

Molecular targets (2)

Target	Gene	Action	Activity
B-lymphocyte antigen CD20	MS4A1	other	EC50 8.37
T-cell surface glycoprotein CD3 epsilon chain	CD3E	other	Kd 8.35

Regulatory approvals (2)

Date	Agency	Marketed as	Applicant	Orphan
2023-07-07	EMA	—	ROCHE REGISTRATION GMBH	Yes
2023-06-15	FDA	—	GENENTECH INC

ATC classification

ATC code	Therapeutic hierarchy
L01FX28	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES › Other monoclonal antibodies and antibody drug conjugates

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Cytokine release syndrome	2908.0
Disease progression	671.2
Immune effector cell-associated neurotoxicity syndrome	397.3
Neutropenia	270.9
Tumour flare	245.2
Death	196.4
Off label use	151.1
Diffuse large B-cell lymphoma recurrent	143.2
COVID-19	134.9
Febrile neutropenia	122.8
Pyrexia	87.2
No adverse event	82.2

Chemical structure

• Molecular formula: —
• Molecular weight: —
• CAS number: —
• InChIKey: —
• PubChem CID: —

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Glofitamab used for?

DrugCentral lists the following indications for Glofitamab: Relapsed or refractory diffuse large B-cell lymphoma.

How does Glofitamab work?

Glofitamab is classified as CD20-directed Antibody Interactions, CD3 Receptor Agonists and CD3-directed Antibody Interactions; its molecular targets in DrugCentral include MS4A1 and CD3E.

When was Glofitamab first approved?

Glofitamab was first approved by the FDA in 2023.

What drug class does Glofitamab belong to?

Glofitamab is in the Bispecific CD20-directed CD3 T Cell Engager class.

Sources

• DrugCentral drug card 5736 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL4298092 — compound record and bioactivity
• DrugBank DB16371 — drug record
• FDA UNII 06P3KLK2J8 — substance identity
• DailyMed: FDA labels for Glofitamab — current prescribing information (label search)
• UniProt P11836 (MS4A1) — target protein
• UniProt P07766 (CD3E) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

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