Drug Profile

Blinatumomab - Amgen

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

Latest Information Update: 28 Aug 2026

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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; Immunoglobulin fragments; Immunotherapies; Recombinant fusion proteins
Mechanism of Action Immunologic 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

04 Aug 2026 Amgen in discussions with US FDA to remove partial clinical hold and resume enrollment of two phase II trials
04 Aug 2026 US FDA places a partial clinical hold pausing enrollment on phase I/II trial in Precursor B-cell lymphoblastic leukaemia-lymphoma (Second-line therapy or greater, In adolescents, In adults, In the elderly)
04 Aug 2026 US FDA places a partial clinical hold pausing enrollment on phase I/II trial in Precursor B-cell lymphoblastic leukaemia-lymphoma (Second-line therapy or greater, In children, In neonates, In infants)

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