This is the pharmaceutical Joint Assessment PTJA12 – on glasdegib for the treatment of acute myeloid leukaemia (AML). In June 2020, the European Commission granted marketing authorisation for Daurismo® (glasdegib), in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary AML in adult patients who are not candidates for standard induction chemotherapy. This Joint Assessment aims to compare the clinical effectiveness and safety of glasdegib, in combination with low-dose cytarabine, in the target patient population with relevant comparators (azacitidine, decitabine, low-dose cytarabine, and best supportive care) according to the national requirements of EUnetHTA partners.
Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report, and responses to the factual accuracy check performed by Pfizer; and the Core Submission Dossier prepared by Pfizer, the Marketing Authorisation Holder of glasdegib.
For any questions regarding the assessment, please contact email@example.com
PTJA12 – Final Project Plan
PTJA12 – Final Assessment Report
PTJA12 – Plain Language Summary
PTJA12 – MAH Core Submission Dossier
PTJA12 – External Comments – Factual Accuracy Check MAH
This website was produced under the Third EU Health Programme through a service contract with the European Health and Digital Executive Agency (HaDEA) acting under the mandate from the European Commission. The information and views set out in this website are those of the author(s) and do not necessarily reflect the official opinion of the Commission/Executive Agency. The Commission/Executive Agency do not guarantee the accuracy of the data included in this website. Neither the Commission/Executive Agency nor any person acting on the Commission’s/Executive Agency’s behalf may be held responsible for the use which may be made of the information contained therein.
©2021 EUnetHTA All rights reserved.