Xegafri: Withdrawal of the marketing authorisation application


On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Xegafri (rociletinib) (PDF/67.46 KB)

    First published: 27/05/2016
    Last updated: 27/05/2016

  • Key facts

    Product number
    Date of withdrawal
    Company making the application
    Clovis Oncology UK Ltd
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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