# Ovarian cancer

The EU has approved 12 indications of 6 drugs in ovarian cancer. 4 of them need a biomarker result: BRCA1/2 (1), FRα (1), HRD (1) and PD-L1 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### BRCA1/2 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | 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 |

### FRα-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Mirvetuximab soravtansine](https://oncolabels.com/drugs/mirvetuximab-soravtansine) (Elahere) | FRα FRα-positive | Monotherapy | 2nd line | High-grade serous only; After 1 to 3 prior systemic treatment regimens; Platinum-resistant |

### HRD positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | 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 |

### PD-L1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1 | + paclitaxel, with or without bevacizumab | 2nd line, advanced | After one or two prior systemic treatment regimens; platinum-resistant |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + carboplatin and paclitaxel | 1st line, advanced | FIGO stage IIIB, IIIC or IV |
| [Niraparib](https://oncolabels.com/drugs/niraparib) (Zejula) | None | Monotherapy | Maintenance, advanced | High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy; FIGO Stages III and IV |
| [Niraparib](https://oncolabels.com/drugs/niraparib) (Zejula) | None | Monotherapy | Maintenance, advanced | High-grade serous only; Platinum-sensitive; in complete or partial response to platinum-based chemotherapy |
| [Olaparib](https://oncolabels.com/drugs/olaparib) (Lynparza) | None | Monotherapy | Maintenance, advanced | High-grade only; Platinum-sensitive relapsed; in complete or partial response to platinum-based chemotherapy |
| [Rucaparib](https://oncolabels.com/drugs/rucaparib) (Rubraca) | None | Monotherapy | Maintenance, advanced | High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy |
| [Rucaparib](https://oncolabels.com/drugs/rucaparib) (Rubraca) | None | Monotherapy | Maintenance, advanced | High-grade only; Platinum-sensitive; in complete or partial response to platinum-based chemotherapy |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + carboplatin and gemcitabine or carboplatin and paclitaxel | 2nd line, advanced | After prior platinum-based therapy; no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents; First recurrence of platinum-sensitive disease |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + paclitaxel, topotecan, or pegylated liposomal doxorubicin | 2nd line, advanced | No more than two prior chemotherapy regimens; no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents; Platinum-resistant disease |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Pembrolizumab** (Keytruda), Ovarian cancer, 2nd line, advanced: “KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Ovarian cancer, 1st line, advanced: “Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. (See section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Ovarian cancer, 2nd line, advanced: “Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Ovarian cancer, 2nd line, advanced: “Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Mirvetuximab soravtansine** (Elahere), Ovarian cancer, 2nd line: “ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens (see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf)
- **Rucaparib** (Rubraca), Ovarian cancer, maintenance, advanced: “Rubraca is indicated as monotherapy for the 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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf)
- **Rucaparib** (Rubraca), Ovarian cancer, maintenance, advanced: “Rubraca is indicated as monotherapy for the 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/rubraca-epar-product-information_en.pdf)
- **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)
- **Niraparib** (Zejula), Ovarian cancer, maintenance, advanced: “as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade 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/zejula-epar-product-information_en.pdf)
- **Niraparib** (Zejula), Ovarian cancer, maintenance, advanced: “as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous 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/zejula-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/tumours/ovarian-cancer