Quizartinib (1) – Vanflyta®
Acute myeloid leukaemia (AML)
Characteristics
| Start date | 01.02.2024 – Marketing authorisation: 06.11.2023 |
|---|---|
| Resolution | 01.08.2024 |
| INN | Quizartinib |
| Brand name | Vanflyta® |
| Pharm. company | Daiichi Sankyo Deutschland GmbH |
| G-BA Procedure ID | D-1038 |
| ATC code | L01EX11 Other protein kinase inhibitors (L01EX) |
| 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 |
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|
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction chemotherapy and standard cytarabine consolidation chemotherapy followed by maintenance therapy with VANFLYTA as monotherapy in adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3-ITD positive | - induction chemotherapy: cytarabine in combination with daunorubicin and midostaurin – followed by consolidation therapy: patient-specific therapy with a choice of chemotherapy (cytarabine in combination with midostaurin) and allogeneic stem cell transplantation, depending in particular on the subtype of AML, the patient's general condition and comorbidity. – followed by maintenance therapy: patient-individualised therapy with selection of – Azacitidine (only for people who are not suitable for an allogeneic stem cell transplant) – Midostaurin (only for people who are not suitable for an allogeneic stem cell transplant) – Sorafenib (only for people after an allogeneic stem cell transplant) taking into account induction and consolidation therapy |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- Clinical trials
- In the completed double-blind Phase III QuANTUM-First trial, quizartinib was compared with placebo across the three phases of induction, consolidation and maintenance therapy.
Adults with newly diagnosed acute myeloid leukaemia (AML) who are FLT3-ITD-positive
- The additional benefit is not proven.
- There are therefore no data available to enable an assessment of the additional benefit.
- An additional benefit of quizartinib compared with the appropriate comparator therapy is therefore not proven.
- Overall assessment
- The data submitted are not suitable for a comparison with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Quizartinib (1) | Vanflyta® | Daiichi Sankyo Deutschland GmbH | Acute myeloid leukaemia (AML) | 260–820 | 100% additional benefit not proven |
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