Rucaparib (3) – Rubraca®

Maintenance therapy for adult female patients with platinum-sensitive, recurrent, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in remission (complete or partial) following platinum-based chemotherapy

• The additional benefit of rucaparib compared with the appropriate comparator therapy is deemed not proven.
• No dossier was submitted by the pharmaceutical manufacturer at the relevant time. Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment will be carried out as to whether the active ingredient rucaparib, within its therapeutic indication as maintenance therapy for adult female patients with platinum-sensitive, recurrent, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in remission (complete or partial) following platinum-based chemotherapy, offers additional benefit, no additional benefit or a less benefit compared with the appropriate comparator therapy, and that the additional benefit of rucaparib relative to the appropriate comparator therapy is deemed not proven.
• Appropriate comparator therapy
  • The appropriate comparator therapy was defined as follows: Maintenance therapy for adult female patients with platinum-sensitive, recurrent, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in remission (complete or partial) following platinum-based chemotherapy
  • Appropriate comparator therapy for rucaparib as monotherapy: patient-specific treatment involving a choice of olaparib, niraparib or watchful waiting (only for patients who have already received a PARP inhibitor); taking into account prior treatment with a PARP inhibitor

Courtesy translation only, please refer to the German original.