Niraparib

Niraparib (Zejula, GlaxoSmithKline Trading Services Limited) has 2 EU-approved indications in 1 tumour type.
Approved indications of Niraparib
Biomarker requirementRegimenSettingConditions
Ovarian cancer2
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
None
Monotherapy
Maint.
advanced
High-grade serous only; Platinum-sensitive; in complete or partial response to platinum-based chemotherapy
Full text of section 4.1 (therapeutic indications)

Zejula is indicated: • 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. • 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.

Label history

26 changes to the Zejula label since 2018, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes