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Mosunetuzumab - Genentech

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Drug Profile

Mosunetuzumab - Genentech

Alternative Names: Anti-CD20/CD3 T-cell dependent bispecific antibody; BTCT 4465A; CD20-TBD; CD20xCD3 T-cell engaging bispecific antibody; Lunsumio; mosunetuzumab-axgb; RG7828; RO7030816

Latest Information Update: 23 Sep 2025

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At a glance

  • Originator Genentech
  • Developer Chugai Pharmaceutical; Genentech; Roche
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Follicular lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Follicular lymphoma
  • Preregistration Non-Hodgkin's lymphoma
  • Phase II Diffuse large B cell lymphoma; Marginal zone B-cell lymphoma
  • Phase I/II Chronic lymphocytic leukaemia
  • Phase I B-cell lymphoma; Systemic lupus erythematosus

Most Recent Events

  • 19 Sep 2025 Preregistration for Follicular lymphoma (Second-line therapy or greater) in European Union (SC)
  • 19 Sep 2025 European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends approval of mosunetuzumab for Follicular lymphoma (Second-line therapy or greater) in European Union (SC)
  • 19 Sep 2025 Updated adverse events data from the phase I/II GO29781 trial in Chronic lymphocytic leukaemia and Non-Hodgkin's lymphoma released by Roche

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