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A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Trial Profile

A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jan 2024

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At a glance

  • Drugs Efbemalenograstim alfa (Primary)
  • Indications Chemotherapy induced febrile neutropenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Evive Biotech
  • Most Recent Events

    • 16 Dec 2023 Results reporting safety and efficacy data published in the Supportive Care in Cancer
    • 07 Jul 2020 According to an Evive Biotech media release, the company progresses its BLA submission with the FDA and equivalent submissions around the world.
    • 24 Jan 2018 According to a Generon Corporation media release, This is one of two pivotal Phase III studies required for BLA submission in the US.
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