Lartruvo

Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo

EMA has completed its assessment of the results of the ANNOUNCE study1 and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. The Agency is therefore recommending that the marketing authorisation of the medicine be revoked.

In January 2019, when preliminary results of the ANNOUNCE study became available, the Agency recommended that no new patients should start treatment with the medicine. Having now assessed the full data from the study, the Agency has concluded that the benefit of Lartruvo in combination with doxorubicin is not confirmed. Regarding safety, the data did not show any new safety concerns.

Lartruvo was authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is paucity of suitable medicines. At the time of its approval, data on the effects of Lartruvo were limited because of the small number of patients included in the main study which supported its authorisation. The medicine was therefore granted a conditional marketing authorisation on condition that the company provided additional data from the ANNOUNCE study.

Key facts

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

olaratumab

Associated names
Lartruvo
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
Opinion provided by Committee for Medicinal Products for Human Use
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:

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