Full marketing authorisation for blinatumomab
The European Commission (EC) has granted a full marketing authorisation for blinatumomab based on data from the phase 3 TOWER study. The study included adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
Blinatumomab was already approved with accelerated approval, which means it’s ‘temporarily approved’ but that further results are needed in the future. The latest approval by the EC means that new results have been submitted and the previous temporary approval is now a full approval (without further results needed).
Read the full details of the approval here.