Odronextamab

Odronextamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHumanized
TargetCD20, CD3
Clinical data
Trade namesOrdspono
Other namesREGN1979; REGN-1979
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6458H9950N1728O2020S46
Molar mass145593.47 g·mol−1

Odronextamab, sold under the brand name Ordspono, is a CD20 x CD3 bispecific monoclonal antibody that is used for the treatment of follicular lymphoma or diffuse large B-cell lymphoma.[1][2] It was developed by Regeneron Pharmaceuticals.[1]

The most common side effects include cytokine release syndrome, infections, neutropenia, pyrexia (fever), anemia, thrombocytopenia, and diarrhea.[1]

Odronextamab was approved for medical use in the European Union in August 2024.[1][2]

Medical uses

Odronextamab is indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy;[1] and for the treatment of adults with relapsed or refractory diffuse large B‑cell lymphoma after two or more lines of systemic therapy.[1]

Side Effects

The most common side effects include cytokine release syndrome, infections, neutropenia, pyrexia, anemia, thrombocytopenia, and diarrhea.[1]

Society and culture

In June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Ordspono, intended for the treatment of follicular lymphoma and diffuse large B-cell lymphoma.[1][3] The applicant for this medicinal product is Regeneron Ireland Designated Activity Company.[1] Odronextamab was approved for medical use in the European Union in August 2024.[1][2][4]

Names

Odronextamab is the international nonproprietary name.[5]

References

  1. ^ a b c d e f g h i j k "Ordspono EPAR". European Medicines Agency (EMA). 27 June 2024. Retrieved 29 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. ^ a b c d "Ordspono Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
  3. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". European Medicines Agency. 28 June 2024. Archived from the original on 12 July 2024. Retrieved 12 July 2024.
  4. ^ "Ordspono (odronextamab) Approved in the European Union for the Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma" (Press release). Regeneron Pharmaceuticals. 26 August 2024. Retrieved 27 August 2024 – via GlobeNewswire.
  5. ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.

Further reading


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