Drug Profile

Blinatumomab - Amgen

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

Latest Information Update: 01 Sep 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; Antirheumatics; 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; Rheumatoid arthritis; Richter's syndrome; Systemic lupus erythematosus
No development reported Burkitt's lymphoma
Discontinued Chronic lymphocytic leukaemia

21 Aug 2025 Amgen plans a phase I/II trial for Precursor B-cell lymphoblastic leukaemia-lymphoma (In neonates, In infants, In children, Second-line therapy or greater) (SC) in November 2025 (NCT07134088)
16 Jul 2025 Phase-II clinical trials in Rheumatoid arthritis (Treatment-experienced) in United Kingdom, Spain, Portugal, Italy, Germany, France, Belgium, USA (SC) (NCT06570798) (Amgen pipeline, August 2025)
14 Jun 2025 Phase-II clinical trials in Systemic lupus erythematosus in USA, United Kingdom, Belgium, France, Germany, Italy, Spain, Porugal (SC) (NCT06570798) (Amgen pipeline, June 2025)

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