LYNPARZA (olaparib)

LynparzaTM (olaparib) is a first‐in‐class PARP inhibitor (PARPi) that allows women with BRCA mutated (BRCAm) platinum‐sensitive relapsed high-grade serous ovarian cancer to extend progression‐free survival (PFS).1-3

Prescribing Information

Unmet need in ovarian cancer

Image of the disease course of a patient with late stage ovarian cancer – showing the decreasing PFS times with multiple lines of chemotherapy.
Image of the disease course of a patient with late stage ovarian cancer – showing the decreasing PFS times with multiple lines of chemotherapy.

CA-125 depicted for illustrative purposes only

Patient eligibility for Lynparza

Patients are eligible for treatment with Lynparza only if they have a confirmed BRCA mutation (can be germline or somatic).4

  • Testing for a BRCA mutation at diagnosis could help provide a timely informed decision on the most appropriate treatment strategy for women with ovarian cancer.
  • All cancer patients with a ≥10% probability of having a BRCAm should be offered genetic testing.15,16 All women with high-grade serous ovarian cancer and Grade 3 endometrioid are therefore eligible for testing.17
  • Those who have a confirmed BRCAm status are eligible for maintenance treatment with Lynparza within the licenced indication.4

EMA licence criteria for Lynparza

Image showing marketing authorisation criteria for Lynparza
Image showing marketing authorisation criteria for Lynparza

Lynparza is indicated as a 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.4

This means that patients can receive Lynparza as a maintenance treatment after their first or any subsequent relapse (i.e. as a second line or beyond maintenance therapy) provided they meet the other eligibility criteria.

NICE reimbursement criteria for Lynparza

Lynparza is recommended by NICE within its marketing authorisation for patients only if:

  • They have had 3 or more courses of platinum based chemotherapy and
  • The drug cost of Lynparza for people who remain on treatment after 15 months will be met by AstraZeneca.5
Image showing NICE criteria for Lynparza
Image showing NICE criteria for Lynparza

SMC criteria for Lynparza

Image showing marketing authorisation criteria for Lynparza
Image showing marketing authorisation criteria for Lynparza

Lynparza is recommended by the SMC in line with its marketing authorisation (i.e. for patients who have had two or more courses of platinum based chemotherapy)6

Patient Profile

This could affect any woman.

Who should be tested for a BRCA mutation?

Early identification of BRCAm status in women diagnosed with ovarian cancer can help identify those who could benefit from risk-reduction strategies18 and inform family members of their increased risk.19

Icon of an older woman
Icon of an older woman

Margaret

Age: 72

Family history: Ovarian cancer

BRCAm are not confined to women who present with ovarian cancer at an earlier age; in fact, over 70% of women with BRCAm are 50 years of age or older at diagnosis.19 ESMO guidelines recommend testing all high-grade serous patients with ovarian cancer for BRCAm status regardless of family history or age.20 NICE recommend all women with a ≥10% chance of having a BRCA gene mutation should be tested;15 BGCS guidelines class all women with high-grade ovarian cancer as having a 10% chance of having a BRCA gene mutation.17

Icon of a woman
Icon of a woman

Valerie

Age: 50

Family history: None

Data suggests that approximately 40% of patients with BRCA-mutated ovarian cancer may have no documented relevant family history.21, 22 Guidelines are evolving to recommend BRCAm testing in all women with high-grade serous ovarian cancer in recognition that many more may have BRCAm beyond those diagnosed at an early age or those with a family history. 15-17, 20

Icon of a young woman
Icon of a young woman

Rachael

Age: 37

Family history: Breast and ovarian cancer

While only 0.1–0.3% of the general population are estimated to carry BRCAm,23-26 approximately 15% of women with ovarian cancer have germline BRCAm, with an even higher prevalence in women with high-grade serous ovarian cancer.22 Restricting genetic testing to patients diagnosed at a young age or those with a family history means that many women with BRCAm may be missed.27