Rucaparib (1) – Rubraca®

Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, after at least 2 previous therapies

Characteristics

Start date 01.03.2019 – Marketing authorisation: 23.05.2018
Resolution 15.08.2019 repealed
INN Rucaparib
Brand name Rubraca®
Pharm. company Dossier: Clovis Oncology Germany GmbH
New distributor: pharmaand GmbH
G-BA Procedure ID D-438
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
DDD 1.2 g O
Therapeutic area Oncological diseases Ovarian cancer / Fallopian tube cancer / Peritoneal cancer
Reason for procedure Initial assessment
Regulatory status Conditional Approval authorisation withdrawn by EMA
Specialty Bundling ACT change

Therapeutic indication of the resolution

Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
Subpopulation Indication Comparator
Treatment of platinum-sensitive, recurrent or progressive, high-grade epithelial ovarian, fallopian tube or peritoneal carcinoma with BRCA mutations. Topotecan or pegylated liposomal doxorubicin (PLD)

Studies and Results

No. of studies
(best subpopulation) 		2 (ARIEL2, Studie 10)
Study design
(best subpopulation) 		Single-arm + other comparison
Meta analysis
(best subpopulation) 		no
ACT change 06.08.2019 – nach Dossiereinreichung, Änderung der Leitlinien

  • Clinical trials
    • To demonstrate the additional benefit, the pharmaceutical manufacturer drew on data from the uncontrolled Rucaparib studies ARIEL2 and Study 10 (CO-338-010), as well as from two studies on appropriate comparator therapy (Gordon 2001 and Kaye 2012).

Adult female patients with platinum-sensitive, recurrent or progressive, high-grade epithelial ovarian, fallopian tube or peritoneal cancer with BRCA mutations (germline and/or somatic), who have been treated with two or more previous lines of platinum-based chemotherapy and cannot tolerate further platinum-containing chemotherapy

  • An additional benefit is not proven.
  • The additional benefit of rucaparib in the treatment of adult female patients with platinum-sensitive, recurrent or progressive, High-grade epithelial ovarian, fallopian tube or peritoneal cancer with BRCA mutations (germline and/or somatic), who have been treated with two or more previous lines of platinum-based chemotherapy and cannot tolerate further platinum-containing chemotherapy, is therefore not proven.
  • Summary of the assessment
    • On the basis of the evidence provided, the additional benefit cannot be assessed. Consequently, the additional benefit is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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