Lartruvo - referral

Current status

European Commission final decision

Overview

EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo

On 26 April 2019, EMA completed its assessment of the results of the ANNOUNCE study 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.
 

Information for patients

• Lartruvo was approved to treat a rare type of cancer called soft tissue sarcoma. It was approved on condition that the company carried out a study to confirm its benefits.
• However, that study showed that Lartruvo with doxorubicin is no better than doxorubicin alone at prolonging patients’ lives.
• The marketing authorisation of Lartruvo will therefore be withdrawn and no new patients will be treated with the medicine.
• If you are already being treated with Lartruvo, your doctor will consider the most appropriate treatment for you.
• There are no new safety concerns with the medicine.

Information for healthcare professionals

• The phase 3 study ANNOUNCE of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma did not confirm the clinical benefit of Lartruvo.
• The study did not meet its primary objective to prolong survival in the overall population (stratified hazard ratio [HR]: 1.05; median 20.4 for Lartruvo plus doxorubicin versus 19.8 months for placebo plus doxorubicin) or in the leiomyosarcoma sub-population (HR: 0.95; median 21.6 months for Lartruvo plus doxorubicin versus 21.9 months for placebo plus doxorubicin).
• Additionally, no benefit was shown in terms of prolonging progression-free survival in the overall population (HR: 1.23; median 5.4 months for Lartruvo plus doxorubicin versus 6.8 months for placebo plus doxorubicin), which was one of the secondary objectives of the study.
• As a consequence, the marketing authorisation of Lartruvo will be revoked and no new patients will be able to receive Lartruvo.
• For patients already on treatment with Lartruvo, doctors should consider the available treatment options.
• No new safety concerns were identified during the study.

More about the medicine

Lartruvo is a cancer medicine that was authorised in the EU on 9 November 2016 to treat adults with advanced soft tissue sarcoma, a type of cancer that affects tissues of the body such as muscles, blood vessels and fat tissue.

Lartruvo was for use together with doxorubicin (another cancer medicine) in patients who could not undergo surgery or radiotherapy (treatment with radiation) and who had not been previously treated with doxorubicin. Lartruvo was to be given in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo alone in patients whose disease has not got worse.

Lartruvo was granted a ‘conditional approval’. At 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 authorisation. The medicine was therefore granted a marketing authorisation on condition that the company provided additional data from the ANNOUNCE study in order to confirm the benefits and safety of the medicine.

More about the procedure

The review of Lartruvo was initiated on 31 January 2019 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.

The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 19 July 2019.

The assessment report with details of the data assessed and the reasons for the revocation is available on EMA’s website. In addition, the Agency is preparing a scientific publication on this first revocation of a conditional marketing authorisation.

Lartruvo Article 20 referral - EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo

Reference Number: EMA/423345/2019

Key facts

About this medicine

• Approved name:
  Lartruvo
• International non-proprietary name (INN) or common name:
  olaratumab
• Associated names:
  Lartruvo

About this procedure

• Current status:
  European Commission final decision
• 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.

• Authorisation model:
  Centrally authorised product(s)

Key dates and outcomes

• CHMP opinion date:
  31/01/2019
• EC decision date:
  19/07/2019

All documents

Procedure started

Lartruvo Article 20 referral - Timetable for the procedure

Reference Number: EMA/CHMP/41311/2019

Lartruvo Article 20 referral - List of questions

Reference Number: EMA/CHMP/41310/2019

Lartruvo Article 20 referral - Notification

Lartruvo Article 20 referral - Review of cancer medicine Lartruvo started

Reference Number: EMA/44343/2019

Opinion provided by Committee for Medicinal Products for human Use

Lartruvo Article 20 referral - EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo

Reference Number: EMA/237662/2019 Rev.1

European Commission final decision

Lartruvo Article 20 referral - Annex II

Lartruvo Article 20 referral - CHMP assessment report

Reference Number: EMA/254126/2019

Lartruvo Article 20 referral - EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo

Reference Number: EMA/423345/2019

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.