Lartruvo

olaratumab

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This is a summary of the European public assessment report (EPAR) for Lartruvo. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Lartruvo.

For practical information about using Lartruvo, patients should read the package leaflet or contact their doctor or pharmacist.

What is Lartruvo and what is it used for?

Lartruvo is a cancer medicine used to treat adults with advanced soft tissue sarcoma, a type of cancer that affects the soft, supportive tissues of the body such as muscles, blood vessels and fat tissue. Lartruvo is used together with doxorubicin (another cancer medicine) in patients who cannot undergo surgery or radiotherapy (treatment with radiation) and who have not been previously treated with doxorubicin.

Because the number of patients with soft tissue sarcoma is low, the disease is considered ‘rare’, and Lartruvo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 February 2015.

How is Lartruvo used?

Lartruvo can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the treatment of cancer.

Lartruvo is available as a solution for infusion (drip) into a vein. During the infusion, patients should be monitored for signs and symptoms of infusion-related reactions and trained staff and equipment for emergency resuscitation should be available.

The recommended dose of Lartruvo is 15 mg per kilogram body weight, given twice over a period of three weeks, on days 1 and 8. These three-week cycles should be repeated until the disease gets worse or side effects become unacceptable. Lartruvo is given in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo alone in patients whose disease has not got worse. Doxorubicin is given on day 1 of each cycle, after the Lartruvo infusion.

For further information, see the package leaflet.

How does Lartruvo work?

The active substance in Lartruvo, olaratumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein called ‘platelet-derived growth factor receptor alpha’ (PDGFRα). This protein is often found on the surface of cells where it plays a role in regulating cell multiplication. In cancers such as soft tissue sarcoma, this protein is present in high levels or is overactive, causing cells to become cancerous. By attaching to PDGFRα on sarcoma cells, Lartruvo is expected to block its activity, thereby slowing down the growth of the cancer.

What benefits of Lartruvo have been shown in studies?

Lartruvo has been investigated in one main study involving 133 adults with advanced soft tissue sarcoma who couldn’t undergo surgery or radiotherapy and who had not been previously treated with anthracyclines (a group of cancer medicines that includes doxorubicin). The study showed that Lartruvo plus doxorubicin was more effective than doxorubicin alone at prolonging the time patients live without their disease getting worse (progression-free survival). Patients treated with Lartruvo plus doxorubicin lived for an average of 6.6 months without their disease getting worse, compared with 4.1 months for patients treated with doxorubicin alone. In addition, patients treated with the combination Lartruvo plus doxorubicin lived overall almost twice as long as patients treated with doxorubicin (26.5 versus 14.7 months, respectively).

What are the risks associated with Lartruvo?

The most common side effects with Lartruvo (which may affect more than 1 in 10 people) include nausea (feeling sick), musculoskeletal pain (bone and muscle pain), neutropenia (low levels of neutrophils, a type of white blood cells that fights infection) and mucositis (inflammation of the body’s moist surfaces, most commonly affecting the mouth and throat). The most frequent side effects which lead to treatment termination were infusion-related reactions (allergic reactions which can be serious, with symptoms such as chills, fever and difficulty breathing) and mucositis. The most serious side effects were neutropenia and musculoskeletal pain.

For the full list of all side effects and restrictions with Lartruvo, see the package leaflet.

Why is Lartruvo approved?

Data from the main study show that Lartruvo in combination with doxorubicin improves progression-free and overall survival of patients with advanced soft tissue sarcoma. However, because of the small number of patients included in the main study, further data will be needed from the company that markets the medicine. With regards to the safety profile of the medicine, it was observed that patients treated with Lartruvo plus doxorubicin experienced an increase in the frequency of side effects; however, in view of the benefits of treatment, side effects were considered tolerable and manageable.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Lartruvo’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Lartruvo has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Lartruvo?

Since Lartruvo has been granted a conditional approval, the company that markets Lartruvo will provide additional data from an ongoing study in order to further confirm the efficacy and safety of the medicine.

What measures are being taken to ensure the safe and effective use of Lartruvo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lartruvo have been included in the summary of product characteristics and the package leaflet.

Other information about Lartruvo

The European Commission granted a marketing authorisation valid throughout the European Union for Lartruvo on 9 November 2016.

For more information about treatment with Lartruvo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Lartruvo : EPAR - Summary for the public BG = bălgarski 2016-11-23  
Lartruvo : EPAR - Summary for the public ES = español 2016-11-23  
Lartruvo : EPAR - Summary for the public CS = čeština 2016-11-23  
Lartruvo : EPAR - Summary for the public DA = dansk 2016-11-23  
Lartruvo : EPAR - Summary for the public DE = Deutsch 2016-11-23  
Lartruvo : EPAR - Summary for the public ET = eesti keel 2016-11-23  
Lartruvo : EPAR - Summary for the public EL = elliniká 2016-11-23  
Lartruvo : EPAR - Summary for the public EN = English 2016-11-23  
Lartruvo : EPAR - Summary for the public FR = français 2016-11-23  
Lartruvo : EPAR - Summary for the public IT = italiano 2016-11-23  
Lartruvo : EPAR - Summary for the public LV = latviešu valoda 2016-11-23  
Lartruvo : EPAR - Summary for the public LT = lietuvių kalba 2016-11-23  
Lartruvo : EPAR - Summary for the public HU = magyar 2016-11-23  
Lartruvo : EPAR - Summary for the public MT = Malti 2016-11-23  
Lartruvo : EPAR - Summary for the public NL = Nederlands 2016-11-23  
Lartruvo : EPAR - Summary for the public PL = polski 2016-11-23  
Lartruvo : EPAR - Summary for the public PT = português 2016-11-23  
Lartruvo : EPAR - Summary for the public RO = română 2016-11-23  
Lartruvo : EPAR - Summary for the public SK = slovenčina 2016-11-23  
Lartruvo : EPAR - Summary for the public SL = slovenščina 2016-11-23  
Lartruvo : EPAR - Summary for the public FI = suomi 2016-11-23  
Lartruvo : EPAR - Summary for the public SV = svenska 2016-11-23  
Lartruvo : EPAR - Summary for the public HR = Hrvatski 2016-11-23  

This EPAR was last updated on 23/11/2016 .

Authorisation details

Product details

Product details for Lartruvo
NameLartruvo
Agency product numberEMEA/H/C/004216
Active substance

olaratumab

International non-proprietary name (INN) or common name

olaratumab

Therapeutic area Sarcoma
Anatomical therapeutic chemical (ATC) code L01XC27
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Lartruvo
Marketing-authorisation holder

Eli Lilly Nederland B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union09/11/2016

Contact address:

Eli Lilly Nederland B.V.
Papendorpseweg 83 
3528 BJ Utrecht
The Netherlands

Product information

Product information

09/11/2016  Lartruvo -EMEA/H/C/004216 --

Name Language First published Last updated
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - Product Information HR = Hrvatski 2016-11-23  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Lartruvo : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Lartruvo : EPAR - Public assessment report HR = Hrvatski 2016-11-23  
CHMP summary of positive opinion for Lartruvo HR = Hrvatski 2016-09-16