PTJA05 – enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation
On 6 Dec 2019, Celgene officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for enasidenib. Since no CHMP opinion will be granted at this stage, EUnetHTA closed this Joint Assessment on 12 Dec 2019. The final Project Plan for the applied indication for enasidenib, with details on the scope and methods for the anticipated assessment, can be found below. Should Celgene reapply to EUnetHTA in the future, the need for an updated Project Plan will have to be assessed.
For further information regarding the withdrawal, please refer to the EMA website.