Lynparza

RSS

olaparib

Authorised
This medicine is authorised for use in the European Union.

Overview

Lynparza is a cancer medicine used for:

  • continuing treatment after initial treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb), and the peritoneum (membrane lining the abdomen) in:
    • women whose cancer has come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has shrunk or cleared the cancer;
    • women newly diagnosed with advanced cancer with mutations (changes) in one or both genes known as BRCA1 and BRCA2 who have been treated with platinum-based chemotherapy and in whom this treatment has shrunk or cleared the cancer;
    • women with advanced cancer that is HRD-positive (homologous recombination deficiency; where one of the mechanisms to repair damaged DNA does not work, which can be due to a defect in certain genes such as BRCA1 and BRCA2) and in whom platinum-based chemotherapy and bevacizumab has shrunk or cleared the cancer;
  • breast cancer which is HER2-negative and has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines, and these medicines have stopped working or they were not suitable;
  • continuing treatment of pancreatic cancer in patients with mutations in BRCA1 or BRCA2 genes, that is metastatic (has spread to other parts of the body) and has not worsened after at least 4 months of platinum-based chemotherapy;
  • metastatic prostate cancer in men with mutations in BRCA1 or BRCA2 genes in whom medical or surgical treatment to lower testosterone levels (castration) did not work and whose cancer has worsened after treatment with other prostate cancer medicines, including a new hormonal agent. 

Lynparza is either used alone or in combination with bevacizumab. It contains the active substance olaparib.

This EPAR was last updated on 09/04/2021

Authorisation details

Product details
Name
Lynparza
Agency product number
EMEA/H/C/003726
Active substance
Olaparib
International non-proprietary name (INN) or common name
olaparib
Therapeutic area (MeSH)
Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XX46
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
16/12/2014
Contact address
SE-151 85 Södertälje
Sweden

Product information

11/02/2021 Lynparza - EMEA/H/C/003726 - II/0042

Contents

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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ovarian cancer

Lynparza is indicated as monotherapy for the:

  • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Lynparza in combination with bevacizumab is indicated for the:

  • maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1).

Breast cancer

Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1).

Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

Adenocarcinoma of the pancreas

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

Prostate cancer

Lynparza is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

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

Related content

How useful was this page?

Add your rating
Average
2 ratings
1 rating
2 ratings