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, Ovarian cancer
Drug	Biomarker requirement	Regimen	Setting	Conditions

BRCA1/2 mutation1
Olaparib Lynparza	BRCA1/2 mutation (germline and/or somatic)	Monotherapy	Maint. advanced	High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy

FRα-positive1
Mirvetuximab soravtansine Elahere	FRα-positive	Monotherapy	2L	High-grade serous only; After 1 to 3 prior systemic treatment regimens; Platinum-resistant

HRD positive1
Olaparib Lynparza	HRD-positive (BRCA1/2 mutation and/or genomic instability)	+ bevacizumab	Maint. advanced	High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy in combination with bevacizumab

PD-L11
Pembrolizumab Keytruda	CPS ≥ 1	+ paclitaxel, with or without bevacizumab	2L advanced	After one or two prior systemic treatment regimens; platinum-resistant

No biomarker required8
Bevacizumab Avastin	None	+ carboplatin and paclitaxel	1L advanced	FIGO stage IIIB, IIIC or IV
Niraparib Zejula	None	Monotherapy	Maint. advanced	High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy; FIGO Stages III and IV
Niraparib Zejula	None	Monotherapy	Maint. advanced	High-grade serous only; Platinum-sensitive; in complete or partial response to platinum-based chemotherapy
Olaparib Lynparza	None	Monotherapy	Maint. advanced	High-grade only; Platinum-sensitive relapsed; in complete or partial response to platinum-based chemotherapy
Rucaparib Rubraca	None	Monotherapy	Maint. advanced	High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy
Rucaparib Rubraca	None	Monotherapy	Maint. advanced	High-grade only; Platinum-sensitive; in complete or partial response to platinum-based chemotherapy
Bevacizumab Avastin	None	+ carboplatin and gemcitabine or carboplatin and paclitaxel	2L 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 Avastin	None	+ paclitaxel, topotecan, or pegylated liposomal doxorubicin	2L 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 approvals6

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

Drug	Biomarker requirement	Regimen	Setting	Conditions

EpCAM1
Catumaxomab Korjuny		Monotherapy	2L	Malignant ascites; not eligible for further systemic anticancer therapy

HER21
Trastuzumab deruxtecan Enhertuconditional	HER2-positive (IHC 3+)	Monotherapy	2L advanced	After prior treatment; No satisfactory treatment options

NTRK fusion3
Entrectinib Rozlytrekconditional		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 Vitrakviconditional		Monotherapy	Any line	Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Repotrectinib Augtyroconditional		Monotherapy	Any line 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 fusion1
Selpercatinib Retsevmo		Monotherapy	Any line advanced	Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older

Biomarkers in ovarian cancer

Label wording12

The sentence from section 4.1 of the SmPC that each indication above comes from.

Pembrolizumab (Keytruda)
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.
Bevacizumab (Avastin)
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).
Bevacizumab (Avastin)
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.
Bevacizumab (Avastin)
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).
Mirvetuximab soravtansine (Elahere)
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).
Rucaparib (Rubraca)
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.
Rucaparib (Rubraca)
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.
Olaparib (Lynparza)
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.
Olaparib (Lynparza)
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.
Olaparib (Lynparza)
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).
Niraparib (Zejula)
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.
Niraparib (Zejula)
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.