EMA Recommends an Extension of Therapeutic Indication for Olaparib

New indication concerns maintenance treatment of adult patients with advanced BRCA1/2-mutated high-grade epithelial ovarian cancer
03 May 2019
Gynaecologic malignancies;  Personalised medicine;  Anticancer agents & Biologic therapy

On 26 April 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product olaparib (Lynparza).

The marketing authorisation holder for this medicinal product is AstraZeneca AB.

The CHMP adopted an extension to one of the existing indications for Lynparza tablets (new text in bold) as follows:

For 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.

For 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.

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the European Commission decision, which will normally be issued 67 days from adoption of the opinion. 

Last update: 03 May 2019

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