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Linvoseltamab - Regeneron Pharmaceuticals

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Drug Profile

Linvoseltamab - Regeneron Pharmaceuticals

Alternative Names: BCMAxCD3 antibody - Regeneron Pharmaceuticals; Lynozyfic; REGN-5458

Latest Information Update: 08 Jul 2025

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At a glance

  • Originator Regeneron Pharmaceuticals
  • Class Antiallergics; Antineoplastics; Bispecific antibodies; Immunoglobulin Fv fragments; Immunotherapies; Recombinant fusion proteins
  • Mechanism of Action Cytotoxic T lymphocyte stimulants; Immunologic cytotoxicity
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Multiple myeloma
  • Phase II Smoldering multiple myeloma
  • Phase I/II Amyloid light-chain amyloidosis
  • Phase I Food hypersensitivity

Most Recent Events

  • 02 Jul 2025 Registered for Multiple myeloma (Second-line therapy or greater) in USA (IV)
  • 02 Jul 2025 Linvoseltamab has boxed warning for Cytokine release syndrome and Neurologic toxicity
  • 02 Jul 2025 Adverse events and efficacy data from the phase-I/II LINKER-MM1 trial in Multiple myeloma released by Regeneron Pharmaceuticals

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