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A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

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Trial Profile

A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Sep 2017

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At a glance

  • Drugs Alectinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions
  • Sponsors Roche
  • Most Recent Events

    • 21 Feb 2017 Results published in a Roche media release.
    • 21 Feb 2017 According to a Roche media release, the European Commission has granted a conditional marketing authorisation for Alecensa (alectinib) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The approval was based on data from this and another trial (NP28673).
    • 16 Dec 2016 According to a Roche media release, the Committee for Medicinal Products for Human Use (CHMP) of EMA has adopted a positive opinion for the use of Alecensa (alectinib) for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with crizotinib. The opinion was based on data from this and another trial (NP28673).
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