Decitabin / Cedazuridin (1) – Inaqovi®
Acute myeloid leukaemia, first line
Characteristics
| Start date | 01.03.2024 – Marketing authorisation: 15.09.2023 |
|---|---|
| Resolution | 15.08.2024 |
| INN | Decitabin/Cedazuridin |
| Brand name | Inaqovi® |
| Pharm. company | Otsuka Pharma GmbH |
| G-BA Procedure ID | D-1030 |
| ATC code | n.d. |
| ICD-10 codes (AIS) | C92.00Acute myeloblastic leukemia with failed remission, C92.01Acute myeloblastic leukemia, in remission, C92.40Acute promyelocytic leukemia with failed remission, C92.41Acute promyelocytic leukemia, in remission, C92.50Acute myelomonocytic leukemia with failed remission, C92.51Acute myelomonocytic leukemia, in remission, C92.60Acute myeloid leukemia with 11q23-abnormality with failed remission, C92.61Acute myeloid leukemia with 11q23-abnormality in remission, C93.00Acute monoblastic/monocytic leukemia with failed remission, C93.01Acute monoblastic/monocytic leukemia, in remission, C94.00Acute erythroid leukemia with failed remission, C94.01Acute erythroid leukemia, in remission, C94.20Acute megakaryoblastic leukemia with failed remission, C94.21Acute megakaryoblastic leukemia, in remission |
| Alpha-ID codes (AIS) | I116143AML M3, I116148AML M4, I116154Acute myeloid leukemia with 11q23 abnormality, I116156Acute myeloid leukemia with 11q23 abnormality in complete remission, I116160AML M5, I116163Acute monoblastic leukemia in complete remission, I116182Acute myeloid leukemia, M7, I17638Acute myeloid leukemia, I24192Acute erythroleukemia, I31089Acute myeloid leukemia in complete remission, I31106Acute promyelocytic leukemia in complete remission, I31107Acute myelomonocytic leukemia in complete remission, I31124Acute erythroleukemia in complete remission, I31131Acute megakaryoblastic leukemia in complete remission |
| Therapeutic area | Oncological diseases Acute myeloid leukemia (AML) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Inaqovi is used as monotherapy in the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy is not an option. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with newly diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy | - Azacitidine, or – decitabine, or – glasdegib in combination with low-dose cytarabine, or – Venetoclax in combination with azacitidine, or – Venetoclax in combination with decitabine |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (ASTX727-0) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
- Clinical trials
- ASTX727-02 is a completed Phase III trial, divided into an open-label, actively controlled phase and a single-arm phase.
Adults with newly diagnosed acute myeloid leukaemia (AML) who are not eligible for standard induction chemotherapy
- The additional benefit is not proven.
- In summary, there are no suitable data available to enable an assessment of additional benefit; therefore, additional benefit of decitabine/cedazuridine is not proven for the treatment of adults with newly diagnosed AML who are not eligible for standard induction chemotherapy.
- Overall assessment
- The results of the registration trial ASTX727-02 are available for the assessment of the additional benefit of decitabine/cedazuridine. As the duration of treatment was too short for both decitabine/cedazuridine and the comparator therapy decitabine in the controlled phase of the trial, there is no adequate comparison with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Decitabin / Cedazuridin (2) | Inaqovi® | Otsuka Pharma GmbH | Acute myeloid leukaemia, first-line treatment, combination with venetoclax | n.d. | active procedure | |
| Decitabin / Cedazuridin (1) | Inaqovi® | Otsuka Pharma GmbH | Acute myeloid leukaemia, first line | 560–840 | 100% additional benefit not proven |
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