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.
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PTJA12 – Final Project Plan
PTJA12 – Final Assessment Report
PTJA12 – Plain Language Summary
PTJA12 – MAH Core Submission Dossier
PTJA12 – External Comments – Factual Accuracy Check MAH
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