On August 29, Amgen (AMGN) announced that the EC (European Commission) approved Blincyto as a monotherapy for pediatric patients with Philadelphia chromosome-negative CD19 positive refractory. This drug was also approved for the treatment of relapsed B-Cell precursor acute lymphoblastic leukemia. This approval was based on Study ’205. In this article, we’ll look at the drug and study, as summarized in the chart below.
Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T cell engager (or BiTE) immunotherapy. It’s the first and only BiTE-approved immunotherapy, and it’s also the first immunotherapy based on the BiTE platform.
In 2015, Blincyto was approved for the treatment of adult patients with Philadelphia chromosome-negative (or Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (or ALL).
About Study ’205
Study ’205 is a Phase 1/2 study that evaluated the efficacy and safety of Blincyto in pediatric patients aged one and older with Ph- refractory or relapsed B-cell precursor acute lymphoblastic leukemia. The total number of patients in the study was 93.
The drug was administered through continuous intravenous infusion. The dosage for Blincyto included five µg/m2 per day for days one to seven, followed by 15 µg/m2 per day for days eight to 28 during the first cycle. This was followed by two weeks off. The dosage was increased to 15 µg/m2 per day for days one to 28, followed by two weeks off in each subsequent cycle.