On July 11, 2017, the FDA approved an expanded indication for blinatumomab (Blincyto; Amgen) to include the treatment of patients with Philadelphia chromosome (Ph)-positive (Ph+), relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This current regular FDA approval also provides confirmation of the 2014 accelerated approval granted to blinatumomab for the treatment of patients with Ph-negative relapsed or refractory B-cell precursor ALL. It also expands the indication to include all patients with relapsed or refractory B-cell precursor ALL, regardless of their Ph chromosome status.
The study that confirmed the initial approval was based on TOWER, a randomized clinical trial that compared blinatumomab and standard-of-care chemotherapy in 405 patients with relapsed or refractory B-cell precursor ALL. Results showed significant improvement in overall survival (OS) with blinatumomab versus chemotherapy (hazard ratio, 0.71; P = .012); the estimated median OS was 7.7 months versus 4.0 months, respectively.
The expanded indication to patients with Ph+ disease was based on ALCANTARA, a single-arm multicenter study of 45 patients with Ph+ relapsed or refractory with relapsed or refractory B-cell precursor ALL. Overall, 36% of patients reached complete remission with blinatumomab, with a median remission duration of 6.7 months.
The 2 studies did not report any new major adverse events.