Midostaurin
Midostaurin (Rydapt, Novartis Europharm Ltd) has 4 EU-approved indications in 2 tumour types. 3 need a biomarker result: FLT3 (3).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Acute myeloid leukaemia3 | |||
FLT3 mutation | + standard daunorubicin and cytarabine | Induction | Then maintenance monotherapy |
FLT3 mutation | Monotherapy | Maint. | After standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy; Complete response |
FLT3 mutation | + high-dose cytarabine | Consol. | After standard daunorubicin and cytarabine induction chemotherapy |
| Systemic mastocytosis1 | |||
None | Monotherapy | Any line | Advanced systemic mastocytosis only (ASM, SM-AHN or MCL) |
Full text of section 4.1 (therapeutic indications)
Rydapt is indicated: • 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); • as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
Label history
15 changes to the Rydapt label since 2018, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes