Olaparib (11) – Lynparza®

Adult female patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic), high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, who have achieved a response (complete or partial) following completion of first-line platinum-based chemotherapy; maintenance therapy

• Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; therefore, there is no additional benefit of olaparib as maintenance therapy in adult female patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic), high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, who have achieved a response (complete or partial) following completion of first-line platinum-based chemotherapy, is not proven.
• Due to the lack of comparison with the appropriate comparator therapy, niraparib, the SOLO-1 trial is not suitable for assessing the additional benefit of olaparib and is therefore not used for the benefit assessment.
• Overall assessment
  • Conclusion
  • Overall, the data presented are not sufficient to demonstrate additional benefit compared with the appropriate comparator therapy; consequently, additional benefit of olaparib is not proven.

Courtesy translation only, please refer to the German original.