Rucaparib
Rucaparib (Rubraca, pharmaand GmbH) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Ovarian cancer2 | |||
None | Monotherapy | Maint. advanced | High-grade only; In complete or partial response following completion of first-line platinum-based chemotherapy |
None | Monotherapy | Maint. advanced | High-grade only; Platinum-sensitive; in complete or partial response to platinum-based chemotherapy |
Full text of section 4.1 (therapeutic indications)
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. 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.
Label history
19 changes to the Rubraca label since 2018, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes