2 Information about midostaurin

Marketing authorisation indication

2.1 Midostaurin (Rydapt, Novartis) is indicated 'in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia who are FLT3 mutation-positive'.

Dosage in the marketing authorisation

2.2 The dose of midostaurin is 50 mg orally twice daily on days 8–21 of induction and consolidation chemotherapy cycles. For patients who have a complete response midostaurin is continued every day as single agent maintenance therapy until relapse, for up to 12 cycles of 28 days each.


2.3 The company stated that the list price of midostaurin is £5,609.94 for 56 capsules. The company has a commercial arrangement. This makes midostaurin available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)