Final Assessment Report, External Comments/Answers and Project Plan for pharma JA on midostaurin (Rydapt©)
This is the assessment of the relative effectiveness of midostaurin (Rydapt©) in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy for patients in complete response, followed by midostaurin monotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive. Relevant alternative therapies had been established based on European guidelines and recommendations.
Final version of the assessment was published in November 2017. Below is the documentation provided by the Joint Assessment authoring team:
PTJA01 Midostaurin Final Assessment Report
External comments and answers 2nd draft assessment midostaurin
Project Plan PTJA01 Midostaurin for AML FINAL_1_0
Project Plan PTJA01_external comments_0_0