New drug approved for acute lymphoblastic leukemia

New drug approved for acute lymphoblastic leukemia

Blinatumomab was granted accelerated approval by the US FDA for the treatment of “Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R ALL)”. The approval was based on the achievement of durable complete remission and response in a clinical trial.

Trial results from 185 patients

1 in 3 patients with relapsed/refractory ALL attained complete remission with 2 cycles of treatment with single-agent blinatumomab and the response was durable.

Furthermore, 31% of the patients had a complete remission, with or without complete hematological recovery, but with reduction in minimal residual disease to <10-4.

What about safety?

Safety was evaluated in 212 patients with R/R ALL treated with blinatumomab. Activation of the immune system results in release of inflammatory cytokines.

However, only 11% of the patients reported Cytokine release syndrome, including life-threatening or fatal events. Information on clinical trial, safety, dosing, drug-drug interactions and contraindications is available from the FDA.