Full FDA Approval Sought for Blinatumomab in Acute Lymphoblastic Leukemia

February 14th, 2017 – A supplemental biologics license application (sBLA) has been submitted to the FDA for the full regulatory approval of blinatumomab as a treatment for patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), according to the developer of the anti-CD19 immunotherapy, Amgen. The sBLA was based on data from the phase III TOWER study, in which the median … (leggi tutto)