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Odronextamab - Regeneron Pharmaceuticals

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Drug Profile

Odronextamab - Regeneron Pharmaceuticals

Alternative Names: CD20xCD3 bispecific antibody - Regeneron Pharmaceuticals; Ordspono; REGN-1979; ZL-1307

Latest Information Update: 10 Mar 2025

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At a glance

  • Originator Regeneron Pharmaceuticals
  • 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 - Diffuse large B cell lymphoma; Follicular lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Diffuse large B cell lymphoma; Follicular lymphoma
  • Phase III Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
  • Phase I B-cell lymphoma; Chronic lymphocytic leukaemia

Most Recent Events

  • 26 Feb 2025 FDA assigns PDUFA action date of (30/07/2025) for odronextamab for Follicular lymphoma
  • 26 Feb 2025 US FDA accepts BLA for Odronextamab for Follicular lymphoma for review
  • 04 Feb 2025 Regeneron Pharmaceuticals stated that the US FDA is expected to make a decision on the sBLA application for odronextamab in Follicular lymphoma (Second-line therapy or greater) in second half of 2025

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