Tyverb

lapatinib

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This is a summary of the European public assessment report (EPAR) for Tyverb. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tyverb.

What is Tyverb?

Tyverb is a medicine that contains the active substance lapatinib. It is available as tablets (250 mg).

What is Tyverb used for?

Tyverb is used to treat patients with breast cancer that has been shown to be ‘expressing’ large amounts of HER2. This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the tumour cells. Tyverb is used in the following ways:

  • in combination with capecitabine (another anticancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of anticancer medicine), and following treatment of the patient’s metastatic disease with trastuzumab (another anticancer medicine). ‘Advanced’ means that the cancer has started to spread and ‘metastatic’ means that the cancer has already spread to other parts of the body;
  • in combination with trastuzumab for advanced or metastatic cancer that does not respond to hormones (hormone-receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other anticancer medicines (chemotherapy);
  • in combination with an aromatase inhibitor (another type of anticancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones. This combination is used in women who do not currently need to receive standard chemotherapy to treat their cancer.

The medicine can only be obtained with a prescription.

How is Tyverb used?

Tyverb should only be started by a doctor who has experience in giving anticancer medicines.

The recommended dose of Tyverb is four tablets a day when used with trastuzumab, five tablets a day when it is used with capecitabine, and six tablets a day when taken with an aromatase inhibitor. All of the tablets must be taken together at the same time every day, at least one hour before or one hour after food. Each patient should take the medicine at the same time each day with respect to food, such as always before or always after a meal. The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver. If patients start to take Tyverb again, they may need to use a lower dose. Patients who stop taking Tyverb after developing severe liver problems should not start to take the medicine again.

How does Tyverb work?

The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein-kinase inhibitors. These compounds work by blocking enzymes known as protein kinases, which can be found in some receptors on the surface of cancer cells including HER2. HER2 is a receptor for a chemical messenger called epidermal growth factor which produces signals that stimulate the cancer cells to divide uncontrollably. By blocking these receptors, Tyverb helps to control cell division and growth of the cancer. About a quarter of breast cancers express HER2.

How has Tyverb been studied?

Tyverb was studied in three main studies involving women with breast cancer.

The first study involved 408 women with advanced or metastatic disease that was expressing large quantities of HER2 who had already been treated with anthracyclines, taxanes and trastuzumab but whose disease had got worse or come back. The study compared Tyverb in combination with capecitabine, with capecitabine taken alone.

The second study involved 1,286 women who had been through the menopause with metastatic breast cancer that was sensitive to hormones. 219 of the women had cancer that was expressing large quantities of HER2. The study compared Tyverb with placebo (a dummy treatment), both of which were taken together with letrozole (an aromatase inhibitor). The women had not received trastuzumab or an aromatase inhibitor before entering this study.

The third study involved 296 women with metastatic disease that got worse despite treatment with other anticancer medicines (including anthracyclines and taxanes) and with combinations of anticancer medicines plus trastuzumab. The study compared Tyverb alone with a combination of Tyverb plus trastuzumab.

In all the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse, which was assessed in scans. The studies also looked at how long the patients survived.

What benefit has Tyverb shown during the studies?

Tyverb in combination with another anticancer medicine was more effective than the comparator treatment in all studies.

In the first study, the women taking Tyverb in combination with capecitabine lived for an average of 23.9 weeks without their disease getting worse, as assessed by their doctors, compared with 18.3 weeks in the women taking capecitabine alone. Women taking Tyverb with capecitabine survived for an average of 75 weeks, and those taking capecitabine alone survived for an average of 64.7 weeks.

In the second study, the women whose cancer was expressing large quantities of HER2 taking Tyverb in combination with letrozole survived for an average of 35.4 weeks without their disease getting worse. This compared with 13 weeks in those taking placebo in combination with letrozole.

In the third study, women taking Tyverb with trastuzumab lived without their disease getting worse for 12 weeks on average, compared with 8.1 weeks in those taking Tyverb alone. In addition, women taking the combination survived for 14 months on average, compared with 9.5 months in those taking Tyverb alone.

What is the risk associated with Tyverb?

The most common side effects with Tyverb (seen in more than 1 patient in 10) are loss of appetite, diarrhoea (which may lead to dehydration), nausea (feeling sick), vomiting, rash and fatigue (tiredness). For the full list of all side effects reported with Tyverb, see the package leaflet.

Tyverb must not be used in people who are hypersensitive (allergic) to lapatinib or any of the other ingredients.

Why has Tyverb been approved?

The CHMP decided that Tyverb’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Tyverb has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular its effects on the spread of breast cancer. Every year, the European Medicines Agency will review any new information that may have become available and this summary will be updated as necessary.

What information is still awaited for Tyverb?

The company that makes Tyverb will perform a study comparing the effects of treatment containing Tyverb and treatment containing trastuzumab on the spread of cancer to the brain.

Other information about Tyverb

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Tyverb on 10 June 2008. The conditional marketing authorisation has been renewed every year.

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

Name Language First published Last updated
Tyverb : EPAR - Summary for the public BG = bălgarski 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public ES = español 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public CS = čeština 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public DA = dansk 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public DE = Deutsch 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public ET = eesti keel 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public EL = elliniká 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public EN = English 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public FR = français 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public IT = italiano 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public LV = latviešu valoda 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public LT = lietuvių kalba 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public HU = magyar 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public MT = Malti 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public NL = Nederlands 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public PL = polski 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public PT = português 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public RO = română 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public SK = slovenčina 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public SL = slovenščina 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public FI = suomi 26/06/2008 14/08/2013
Tyverb : EPAR - Summary for the public SV = svenska 26/06/2008 14/08/2013

This EPAR was last updated on 29/09/2014 .

Authorisation details

Product details

Product details for Tyverb
NameTyverb
Agency product numberEMEA/H/C/000795
Active substance

lapatinib

International non-proprietary name (INN) or common name

lapatinib

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XE07
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

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 Tyverb
Marketing-authorisation holder

Glaxo Group Limited

Revision20
Date of issue of marketing authorisation valid throughout the European Union10/06/2008

Contact address:

Glaxo Group Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Product information

Product information

24/07/2014  Tyverb -EMEA/H/C/000795 -II/0033

Name Language First published Last updated
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014
Tyverb : EPAR - Product Information SV = svenska 17/11/2009 29/09/2014

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
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012
Tyverb : EPAR - All Authorised presentations SV = svenska 26/06/2008 21/06/2012

Pharmacotherapeutic group

Protein-kinase inhibitors

Therapeutic indication

Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2):

  • in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1);
  • in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy (see section 5.1);
  • in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor (see section 5.1). No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Tyverb : EPAR - Public assessment report SV = svenska 26/06/2008  
Committee for medicinal products for human use, summary of positive opinion for Tyverb SV = svenska 24/04/2008  

Authorised

This medicine is approved for use in the European Union