Odronextamab: First Approval

Drugs. 2024 Dec;84(12):1651-1658. doi: 10.1007/s40265-024-02112-6. Epub 2024 Nov 19.

Abstract

Odronextamab (Ordspono), a CD20xCD3 bispecific antibody, is being developed by Regeneron Pharmaceuticals for the treatment of B-cell non-Hodgkin's lymphoma. On 26 August 2024, odronextamab received its first approval in the EU as monotherapy for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) or relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after ≥ 2 lines of systemic therapy. Clinical trials in various other B-cell non-Hodgkin's lymphoma, including mantle cell lymphoma, marginal zone lymphoma and chronic lymphocytic leukaemia, are underway in multiple countries. This article summarizes the milestones in the development of odronextamab leading to this first approval for the treatment of adult patients with relapsed/refractory FL or relapsed/refractory DLBCL.

MeSH terms

  • Adult
  • Antibodies, Bispecific* / pharmacology
  • Antibodies, Bispecific* / therapeutic use
  • Antigens, CD20 / immunology
  • Antineoplastic Agents / pharmacology
  • Antineoplastic Agents / therapeutic use
  • Drug Approval*
  • Humans
  • Lymphoma, Follicular* / drug therapy
  • Lymphoma, Large B-Cell, Diffuse* / drug therapy

Substances

  • Antibodies, Bispecific
  • Antigens, CD20
  • Antineoplastic Agents