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A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

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Trial Profile

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2025

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At a glance

  • Drugs Odronextamab (Primary) ; Bendamustine; Cyclophosphamide; Doxorubicin; Prednisolone; Prednisone; Rituximab; Rituximab; Vincristine
  • Indications Follicular lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms OLYMPIA-1
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 26 Feb 2025 According to a Regeneron Pharmaceuticals media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2). The target action date for the FDA decision is July 30, 2025.
  • 04 Feb 2025 According to a Regeneron Pharmaceuticals media release, the Company resubmitted to the FDA the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma.
  • 13 Jan 2025 According to a Regeneron Pharmaceuticals media release, enrollment is underway for this confirmatory study to support resubmission of the BLA for FL to the FDA in the first quarter of 2025.

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