On June 21, the U.S. Food and Drug Administration (FDA) approved the supplemental biologics license application for blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with measurable residual disease (MRD) ≥ 0.1%, based on additional data from two phase III studies that were submitted. The FDA’s decision converts blinatumomab’s accelerated approval to full approval.
Blinatumomab is a bispecific T-cell engager immuno-oncology therapy that targets CD19 surface antigens on B cells. Bispecific T-cell engager molecules fight cancer by helping the immune system detect and target malignant cells by engaging T cells to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer apoptosis.
The two phase III trials submitted for conversion to full approval were:
- AALL1331 (NCT02101853), which compared the efficacy of blinatumomab with that of standard combination chemotherapy in younger patients (aged 1–31) with relapsed B-cell ALL
- 20120215 (NCT02393859), which compared blinatumomab to standard chemotherapy in pediatric patients with high-risk B-precursor ALL in first relapse.
"In a phase II study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response," said Elias Jabbour, MD, of the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. "The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population."
Blinatumomab was granted Breakthrough Therapy and Priority Review designations by the FDA.
