Rydapt (midostaurin)
- Region
- 🇪🇺 EU
- Active substance
- midostaurin
- Company
- Novartis Europharm Ltd
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute; Mastocytosis
- CHMP opinion
- Thu 22 Jun 2017
- EU approval
- Mon 18 Sep 2017
- Designations
- Orphan
- Application
- EMEA/H/C/004095
- ATC
- L01XE
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.