Lartruvo

Current status:
Procedure started

Overview

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.


1https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-000134-30

Key facts

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

olaratumab

Reference number
EMEA/H/A-20/1479/C/4216/015
Type
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.

Status
Procedure started
Opinion date
31/01/2019

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:

News

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