FDA Grants Full Approval to Blinatumomab for MRD-Positive B-Cell Precursor ALL
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.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.