Blinatumomab (Blincyto) for Acute Lymphoblastic Leukemia

The median age of patients was 39, the majority of patients had and ECOG PS of 0 (33.9%) or 1 (49.2%) and a small minority of patients had and ECOG PS of 2 (16.4%). [...] The median age of patients was 32, the majority of patients had and ECOG PS of 0 (41.7%) or 1 (52.8%) and a small minority of patients had and ECOG PS of 2 (5.6%). [...] When using 1.7m2 to represent the weight of the average patient (standard of 1.7m2 is used in pCODR reviews for the average weight of patients), the daily dose of blinatumomab between the two studies is nearly equivalent. [...] Factors that the CGP felt worthy of note and which may impact the comparability of results to the MT 103-211 study regarding the historical cohort include the following: • The cohort is one of the largest cohorts of ALL patients described so far. [...] Based on this, the CGP re-iterated that the toxicity profile of blinatumomab are similar to those described in series of patients treated with re-induction chemotherapy as is described in available literature and clinical experience of the Panel.