Blincyto Get FDA Full Approval

FDA has granted full approval to Amgen’s previously accelerated-approved BLA for Blincyto (blinatumomab) for treating adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. The company says that the full approval was based on additional data from two Phase 3 studies.

Blincyto is described by Amgen as a BiTE (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules help the body’s immune system detect and target malignant cells by engaging T cells against cancer cells. “By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis),” it says.

Amgen says BiTE immuno-oncology therapies are currently being studied for their potential to treat a variety of other cancers.