Olaparib (11) – Lynparza®
Ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, BRCA-mutated, FIGO stages III and IV, maintenance therapy
Characteristics
| Start date | 01.04.2023 – Marketing authorisation: 12.06.2019 |
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| Resolution | 21.09.2023 |
| INN | Olaparib |
| Brand name | Lynparza® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-929 |
| ATC code | L01XK01 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 |
Reassessment: G-BA limitation
Original resolution: Olaparib (4) (16.01.2020) |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
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Lynparza is used as monotherapy for the: Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic), high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma who have a response (complete or partial) following completed first-line platinum-based chemotherapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with advanced (FIGO stages III and IV) BRCA1/2 mutated (germline and/or somatic), high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma who have a response (complete or partial) after completed first-line platinum-based chemotherapy; maintenance therapy. | Niraparib |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| ACT change | 28.03.2023 – Neue Leitlinien |
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.
Associated procedures
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