FLT3 in acute myeloid leukaemia
7 EU-approved indications in acute myeloid leukaemia need a FLT3 result: quizartinib (induction), quizartinib (consolidation), quizartinib (maintenance), gilteritinib (2nd line), midostaurin (induction), midostaurin (consolidation) and midostaurin (maintenance).
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| FLT3 mutation7 | ||||
Rydapt | + standard daunorubicin and cytarabine | Induction | Then maintenance monotherapy | |
Vanflyta | FLT3-ITD | + standard cytarabine and anthracycline induction chemotherapy | Induction | Then maintenance monotherapy |
Rydapt | Monotherapy | Maint. | After standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy; Complete response | |
Vanflyta | FLT3-ITD | Monotherapy | Maint. | After quizartinib + standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy without progression |
Rydapt | + high-dose cytarabine | Consol. | After standard daunorubicin and cytarabine induction chemotherapy | |
Vanflyta | FLT3-ITD | + standard cytarabine consolidation chemotherapy | Consol. | After quizartinib + standard cytarabine and anthracycline induction chemotherapy |
Xospata | Monotherapy | 2L | Relapsed or refractory | |
2 approvals for AML need no biomarker and apply whatever the result. All approvals for AML
See also
Label wording7
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Quizartinib (Vanflyta)
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.
- Quizartinib (Vanflyta)
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.
- Quizartinib (Vanflyta)
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.
- Gilteritinib (Xospata)
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1).
- Midostaurin (Rydapt)
in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);
- Midostaurin (Rydapt)
in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);
- Midostaurin (Rydapt)
in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);