Trastuzumab subcutaneous - Roche

Drug Profile

Trastuzumab subcutaneous - Roche

Alternative Names: Herceptin SC; Hyaluronidase-trastuzumab; Reformulated Herceptin - Halozyme/Roche; RG597 (SC formulation) - Roche/Halozyme; Trastuzumab SC; Trastuzumab-hyaluronidase

Latest Information Update: 31 Oct 2018

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At a glance

  • Originator Roche
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action ERBB 2 receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Marketed Breast cancer

Most Recent Events

  • 30 Oct 2018 FDA assigns PDUFA action date of (16/06/2019) for Trastuzumab subcutaneous for Breast cancer
  • 17 Sep 2018 Registered for Breast cancer (Early-stage disease) in Canada (SC)
  • 12 Jul 2018 Roche completes the phase III ESCAPE trial in Breast cancer (Early-stage disease, Second-line therapy or greater) in Belarus and Kazakhstan (SC) (NCT02194166)
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