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).
Lynparza : EPAR - Medicine overview (PDF/85.18 KB) (updated)
First published: 09/01/2015
Last updated: 02/08/2019
Lynparza : EPAR - Risk-management-plan summary (PDF/108.71 KB)
First published: 09/01/2015
Last updated: 11/07/2019
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12/06/2019 Lynparza - EMEA/H/C/003726 - II/0023
- 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
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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 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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 201901/03/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 201823/02/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 October 201424/10/2014