Drug Profile

Blinatumomab - Amgen

Alternative Names: AMG-103; Blincyto; MEDI-538; MT-103

Latest Information Update: 27 Jun 2025

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At a glance

Originator Micromet Inc
Developer Amgen; Astellas Pharma; BeOne Medicines; M. D. Anderson Cancer Center; Merck & Co; Micromet Inc; National Cancer Institute (USA); University of British Columbia; University of California, Davis
Class Antineoplastics; Bispecific antibodies; Immunotherapies
Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Precursor cell lymphoblastic leukaemia-lymphoma; Mantle-cell lymphoma; B-cell prolymphocytic leukaemia; B-cell lymphoma; T-cell prolymphocytic leukaemia; Chronic lymphocytic leukaemia; Hairy cell leukaemia
New Molecular Entity Yes

Marketed Precursor B-cell lymphoblastic leukaemia-lymphoma
Phase II/III Non-Hodgkin's lymphoma
Phase II Diffuse large B cell lymphoma; Richter's syndrome; Systemic lupus erythematosus
No development reported Burkitt's lymphoma
Discontinued Chronic lymphocytic leukaemia

14 Jun 2025 Phase-II clinical trials in Systemic lupus erythematosus in USA, USA, Belgium, France, Germany, Italy, Spain (SC) (NCT06570798) (Amgen pipeline, June 2025)
28 Mar 2025 No recent reports of development identified for phase-I development in Precursor-B-cell-lymphoblastic-leukaemia-lymphoma(In adolescents, In children, In infants, In neonates, In adults) in South Korea (IV, Infusion)
29 Jan 2025 The EMA approves Blinatumomab for Precursor B-cell lymphoblastic leukaemia-lymphoma (Monotherapy) as consolidation therapy in the European Union

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