Lynparza

RSS

olaparib

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

Overview

Lynparza is a cancer medicine used on its own for:

  • continuing 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 had come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has reduced or cleared the cancer;
    • in newly diagnosed women 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 reduced or cleared the cancer;
  • treatment of breast cancer which is HER2-negative and that has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines (unless these medicines were not suitable).
This EPAR was last updated on 12/11/2019

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
L01
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
16/12/2014
Contact address
SE-151 85 Södertälje
Sweden

Product information

01/10/2019 Lynparza - EMEA/H/C/003726 - R/0029

Contents

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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.

 

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.

 

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

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