Drug Profile


Alternative Names: Amrubicin hydrochloride; Calsed; CNF3140; S 5887; SM-5887

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Dainippon Sumitomo Pharma
  • Developer Celgene Corporation; Icahn School of Medicine at Mount Sinai; SCRI Development Innovations; Sumitomo Dainippon Pharma
  • Class Anthracyclines; Cytostatic antibiotics; Small molecules
  • Mechanism of Action DNA intercalators; Type II DNA topoisomerase inhibitors
  • Orphan Drug Status

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

    Yes - Small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer; Small cell lung cancer
  • Phase I/II Breast cancer
  • Discontinued Bladder cancer

Most Recent Events

  • 22 Jun 2015 Amrubicin is still in Preregistration for Small cell lung cancer (First-line therapy) in China
  • 22 Jun 2015 No recent reports on development identified - Phase-II for Small cell lung cancer (First-line therapy, Combination therapy) in European Union (IV)
  • 22 Jun 2015 No recent reports on development identified - Phase-III for Small cell lung cancer (Second-line therapy or greater) in USA, European Union, Canada, Switzerland and Australia (IV)
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