Rucaparib (4) – Rubraca®

Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, maintenance therapy after first-line therapy

Characteristics

Start date 15.12.2023 – Marketing authorisation: 15.11.2023
Resolution 06.06.2024
INN Rucaparib
Brand name Rubraca®
Pharm. company Dossier: Pharmaand Deutschland GmbH
New distributor: pharmaand GmbH
G-BA Procedure ID D-1031
ATC code L01XK03 PARP inhibitors (L01XK)
ICD-10 codes (AIS) C48.0Malignant neoplasm of retroperitoneum, C48.1Malignant neoplasm of cul-de-sac, C48.2Malignant neoplasm of peritoneum, unspecified, C48.8Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum, C56Malignant neoplasm of ovary, C57.0Malignant neoplasm of oviduct, C57.1Malignant neoplasm of broad ligament, C57.3Malignant neoplasm of uterine ligament NOS, C57.4Malignant neoplasm of uterine adnexa, unspecified
Alpha-ID codes (AIS) I105561Malignant neoplasm of the parietal peritoneum, I127389Primary peritoneal carcinoma, I12785Malignant neoplasm of the retroperitoneum, I20716Ovarian cancer, I30230Fallopian tube carcinoma, I30231Malignant neoplasm of the ligamentum latum uteri, I30237Malignant neoplasm of the parametrium, I30243Malignant neoplasm of the uterine adnexa
Therapeutic area Oncological diseases Ovarian cancer / Fallopian tube cancer / Peritoneal cancer
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Rubraca is used as monotherapy for maintenance treatment in adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in remission (complete or partial) after completion of first-line platinum-based chemotherapy
Subpopulation Indication Comparator
Adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in remission (complete or partial) after completion of platinum-based first-line chemotherapy; maintenance therapy A patient-specific therapy under selection of: – Bevacizumab – olaparib – Niraparib – Olaparib in combination with bevacizumab, taking into account – the previous therapy – the presence of a BRCA 1/2 mutation – the presence of genomic instability

Studies and Results

No. of studies
(best subpopulation) 		1 (ATHENA-MONO) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + no ITC)

Adult female patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in remission (complete or partial) following completion of first-line platinum-based chemotherapy; Maintenance therapy

  • For maintenance therapy in adult female patients with advanced epithelial (FIGO stages III and IV) high-grade carcinoma of the ovaries, fallopian tubes or primary peritoneal carcinoma, who are in remission (complete or partial) following completion of first-line platinum-based chemotherapy, an additional benefit is not proven.
  • In summary, there are no suitable data available to enable an assessment of the additional benefit, which is why the additional benefit of rucaparib is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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