Durvalumab (7) – Imfinzi®
Primarily advanced or relapsed endometrial cancer, first-line therapy, combination with carboplatin and paclitaxel; maintenance therapy
Characteristics
| Start date | 01.09.2024 – Marketing authorisation: 26.07.2024 |
|---|---|
| Resolution | 20.02.2025 |
| INN | Durvalumab |
| Brand name | Imfinzi® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-1091 |
| ATC code | L01FF03 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C54.1Malignant neoplasm of endometrium |
| Alpha-ID codes (AIS) | I27788Endometrial carcinoma |
| Therapeutic area | Oncological diseases Endometrial cancer (EC) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are eligible for systemic therapy, followed by maintenance treatment with Imfinzi as monotherapy in endometrial carcinoma with mismatch repair deficiency (dMMR). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with primary advanced endometrial carcinoma (stage III or IV) or recurrent endometrial carcinoma with mismatch repair deficiency (dMMR) who have not yet received systemic therapy for the treatment of – have not yet received systemic therapy as postoperative or adjuvant therapy for the treatment of primary advanced disease – have not yet received chemotherapy for the recurrence | Dostarlimab in combination with carboplatin and paclitaxel followed by Dostarlimab as monotherapy |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (DUO-E) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
Adult female patients with primary advanced endometrial cancer (stage III or IV) or recurrent endometrial cancer with mismatch repair deficiency (dMMR), who, for the treatment of − the primary advanced disease, have not yet received any systemic therapy as post-operative or adjuvant therapy, − the recurrence, have not yet received any chemotherapy
- The additional benefit is not proven.
- The results presented from the DUO-E trial are not suitable for assessing additional benefit, as the appropriate comparator therapy specified by the G-BA (dostarlimab in combination with carboplatin and paclitaxel followed by dostarlimab as monotherapy) has not been implemented in the comparative therapy used in the DUO-E study.
Courtesy translation only, please refer to the German original.
Associated procedures
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