# Olaparib

Olaparib (Lynparza, AstraZeneca AB) has 10 EU-approved indications in 5 tumour types. 7 need a biomarker result: BRCA1/2 (6) and HRD (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Germline BRCA1/2 mutation, HER2-negative | + endocrine therapy | Adjuvant, early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
| Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Adjuvant, early | After neoadjuvant or adjuvant chemotherapy; High risk of recurrence |
| Germline BRCA1/2 mutation, HER2-negative | Monotherapy | Advanced | After anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless not suitable; if HR-positive, progressed on or after prior endocrine therapy, or considered unsuitable for endocrine therapy |

### Pancreatic cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Germline BRCA1/2 mutation | Monotherapy | Maintenance, metastatic | After minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen without progression |

### Ovarian cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HRD-positive (BRCA1/2 mutation and/or genomic instability) | + bevacizumab | Maintenance, advanced | High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy in combination with bevacizumab |
| BRCA1/2 mutation (germline and/or somatic) | Monotherapy | Maintenance, advanced | High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy |
| None | Monotherapy | Maintenance, advanced | High-grade only; Platinum-sensitive relapsed; in complete or partial response to platinum-based chemotherapy |

### Endometrial cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Mismatch repair proficient | + durvalumab | Maintenance, advanced | After first-line treatment with durvalumab in combination with carboplatin and paclitaxel without progression |

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + abiraterone and prednisone or prednisolone | 1st line, metastatic | Castration-resistant only; Chemotherapy is not clinically indicated; castration-resistant Ambiguous in the label (line of therapy): check the SmPC. |
| BRCA1/2 mutation (germline and/or somatic) | Monotherapy | 2nd line, metastatic | Castration-resistant only; After prior therapy that included a new hormonal agent; Castration-resistant |

## Products

### Lynparza

- Company: AstraZeneca AB
- Target: PARP inhibitor
- Class: Poly (adp-ribose) polymerase (PARP) inhibitors
- ATC: L01XK01
- EU approval: 16 Dec 2014
- Label revised: 19 Feb 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lynparza-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza

Mechanism (SmPC section 5.1): Olaparib inhibits PARP-1, PARP-2, and PARP-3 and traps PARP on DNA, blocking single-strand break repair and inducing double-strand breaks that lead to cell death in homologous recombination-deficient tumour cells.

## Label wording

- **Olaparib** (Lynparza), Ovarian cancer, maintenance, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Ovarian cancer, maintenance, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Ovarian cancer, maintenance, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, adjuvant, early: “monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, adjuvant, early: “monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Breast cancer, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Pancreatic cancer, maintenance, metastatic: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Prostate cancer, 2nd line, metastatic: “as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Prostate cancer, 1st line, metastatic: “in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)
- **Olaparib** (Lynparza), Endometrial cancer, maintenance, advanced: “Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/olaparib