Lynparza

olaparib

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About

An overview of Lynparza and why it is authorised in the EU

Lynparza is a cancer medicine for treating recurring high-grade cancers of the ovary, fallopian tube (tubes connecting the ovary to the womb) and the peritoneum (a membrane lining the abdomen).

Lynparza is used as a maintenance treatment after the cancer has been reduced or cleared by a platinum-based chemotherapy.

It contains the active substance olaparib.

How is Lynparza used?

Lynparza is available as tablets (100 and 150 mg) and capsules (50 mg) which the patient takes twice a day. The doses in milligrams are different for the tablets and capsules. Furthermore the capsules must be taken without food while tablets can be taken with or without food.

Treatment should start no later than 8 weeks after the patient has completed their chemotherapy and continue for as long as the disease is not getting worse.

The medicine can only be obtained with a prescription. For more information about using Lynparza, see the package leaflet or contact your doctor or pharmacist.

How does Lynparza work?

The active substance in Lynparza, olaparib, blocks the action of enzymes called human poly (ADP ribose) polymerase (PARP), which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division. Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.

What benefits of Lynparza have been shown in studies?

Studies show that Lynparza increases the time patients can live without their disease getting worse after initial treatment with a platinum chemotherapy has reduced or cleared the tumours.

A study of 295 patients with recurring cancer of the ovary, fallopian tube or peritoneum showed that those patients who took Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients who took placebo (a dummy treatment).

In another study involving 265 patients, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.

What are the risks associated with Lynparza?

The most common side effects with Lynparza (which may affect more than 1 in 10 people) are fatigue (tiredness), nausea (feeling sick), vomiting, diarrhoea, dyspepsia (heartburn), headache, dysgeusia (taste disturbances), decreased appetite, dizziness, anaemia (low red blood cell counts) and cough. For the full list of side effects and restrictions with Lynparza, see the package leaflet.

Why is Lynparza authorised in the EU?

Patients with ovarian, fallopian tube or peritoneal cancers generally have a poor outcome. Lynparza can increase the time these patients live without their disease getting worse, thereby delaying their next cycle of platinum chemotherapy.

The side effects seen with Lynparza were mostly mild or moderate and were generally manageable. The European Medicines Agency therefore decided that Lynparza’s benefits are greater than its risks and it can be authorised for use in the EU.

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

The company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit of the medicine in patients with ovarian cancer.

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

As for all medicines, data on the use of Lynparza are continuously monitored. Side effects reported with Lynparza are carefully evaluated and any necessary action taken to protect patients.

Other information about Lynparza

Lynparza received a marketing authorisation valid throughout the EU on 16 December 2014.

Name Language First published Last updated
Lynparza : EPAR - Medicine overview BG = bălgarski 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview ES = español 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview CS = čeština 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview DA = dansk 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview DE = Deutsch 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview ET = eesti keel 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview EL = elliniká 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview FR = français 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview IT = italiano 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview LV = latviešu valoda 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview LT = lietuvių kalba 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview HU = magyar 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview MT = Malti 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview NL = Nederlands 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview PL = polski 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview PT = português 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview RO = română 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview SK = slovenčina 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview SL = slovenščina 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview FI = suomi 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview SV = svenska 2015-01-09 2018-05-28
Lynparza : EPAR - Medicine overview HR = Hrvatski 2015-01-09 2018-05-28
Name Language First published Last updated
Lynparza : EPAR - Risk-management-plan summary (English only) 2015-01-09  

This EPAR was last updated on 28/05/2018 .

Authorisation details

Product details

Product details for Lynparza
NameLynparza
Agency product numberEMEA/H/C/003726
Active substance

olaparib

International non-proprietary name (INN) or common name

olaparib

Therapeutic area Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code L01
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.

Publication details

Publication details for Lynparza
Marketing-authorisation holder

AstraZeneca AB

Revision4
Date of issue of marketing authorisation valid throughout the European Union16/12/2014

Contact address:

AstraZeneca AB
SE-151 85 Södertälje
Sweden

Product information

Product information

08/05/2018  Lynparza -EMEA/H/C/003726 -X/0016/G

Name Language First published Last updated
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - Product Information EN = English 2015-01-09 2018-05-28

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
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28
Lynparza : EPAR - All Authorised presentations EN = English 2015-01-09 2018-05-28

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Lynparza : Withdrawal assessment report orphan maintenance EN = English 2018-05-28  
Lynparza : EPAR - Public assessment report EN = English 2015-01-09  
CHMP summary of positive opinion for Lynparza EN = English 2014-10-24  

Authorised

This medicine is approved for use in the European Union

More information on Lynparza

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 6 December 2007.

Lynparza was withdrawn from the Community register of orphan medicinal products in March 2018 upon request of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.