Odronextamab - Regeneron Pharmaceuticals
Alternative Names: CD20xCD3 bispecific antibody - Regeneron Pharmaceuticals; Ordspono; REGN-1979; ZL-1307Latest Information Update: 10 Mar 2025
Price :
$50 *
At a glance
- Originator Regeneron Pharmaceuticals
- Class Antineoplastics; Bispecific antibodies; Immunotherapies
- Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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