Rucaparib (1) – Rubraca®

• 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.