A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety OF ABP 215 Compared with Bevacizumab in Subjects with Advanced Non-Small Cell Lung Cancer

Trial Profile

A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety OF ABP 215 Compared with Bevacizumab in Subjects with Advanced Non-Small Cell Lung Cancer

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2017

At a glance

  • Drugs Bevacizumab (Primary) ; Carboplatin; Paclitaxel
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen
  • Most Recent Events

    • 07 Jun 2017 According to an Amgen media release, the US FDA will review data supporting the BLA for ABP 215 on July 13, 2017. The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of September 14, 2017, for ABP 215.
    • 02 Jun 2017 Results assessing the pharmacokinetics, clinical efficacy, safety, and immunogenicity of ABP 215 and bevacizumab in patients with advanced non-small cell lung cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 02 Dec 2016 According to an Amgen media release, Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) for ABP 215 based on data from this trial.
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