Drug Profile


Alternative Names: anti-HER3 monoclonal antibody - Roche; GE-HuMAb-HER3; HER3 MAb solid tumours - Roche; RG-7116; RO-5479599

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Roche
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action ERBB-3 receptor antagonists; Immunomodulators
  • 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

  • Phase I/II Non-small cell lung cancer
  • Phase I Breast cancer; Solid tumours

Most Recent Events

  • 07 Oct 2016 Safety and efficacy data from a phase I trial in Solid tumours presented at the 41st European Society of Medical Oncology Congress (ESMO-2016)
  • 01 Oct 2016 Roche completes a phase I trial in Breast cancer (Combination therapy, Metastatic disease) in Denmark, France, Germany and Spain (IV) (NCT01918254)
  • 18 Jul 2016 Biomarkers information updated
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