Current status:
Procedure started


Review of cancer medicine Lartruvo started

EMA has started a review of the cancer medicine Lartruvo (olaratumab) after preliminary results from the ANNOUNCE study1, which was requested at the time of authorisation in 2016, became available. These show that adding Lartruvo to doxorubicin does not prolong the lives of patients with soft tissue sarcoma more than doxorubicin alone.

Based on the preliminary results of the study, EMA has already recommended that no new patients should start treatment with the medicine, and healthcare professionals have been informed in writing of the updated treatment recommendations.

EMA will now assess the impact of the full study results on the medicine’s authorised use and recommend whether Lartruvo’s marketing authorisation in the EU should be maintained, varied or suspended.


Key facts

Approved name
International non-proprietary name (INN) or common name


Associated names
Reference number
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Procedure started
Opinion date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:


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