Today, the U.S. Food and Drug Administration (FDA) approved BLINCYTO® (blinatumomab) for treating adult and pediatric patients (one month or older) with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
“B-ALL is an aggressive blood cancer with a high unmet need. BLINCYTO has helped thousands of patients over the last 10 years. This approval allows us to reach more patients with this transformative BiTE® therapy,” said Jay Bradner, M.D., executive vice president at Amgen.
The approval is based on the Phase 3 E1910 clinical trial by ECOG-ACRIN Cancer Research Group. This trial studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment. Results showed BLINCYTO added to multiphase consolidation chemotherapy had superior overall survival (OS) compared to chemotherapy alone. The 3-year OS was 84.8% in the BLINCYTO plus chemotherapy group versus 69% in the chemotherapy group, with a hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO group and 62.5% in the chemotherapy group.
“In the E1910 study, blinatumomab reduced the risk of death and significantly improved overall survival,” said Selina M. Luger, M.D., professor at the University of Pennsylvania and an investigator on the study. “This approval redefines the standard of care for B-ALL patients.”
“The risk of B-ALL recurrence after initial treatment is high, making this approval noteworthy,” said E. Anders Kolb, M.D., president and CEO of The Leukemia & Lymphoma Society. “Having an effective option available earlier in treatment is critical for clinicians and patients.”
The E1910 study was sponsored by ECOG-ACRIN with public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and Amgen provided BLINCYTO and support.
About Acute Lymphoblastic Leukemia (ALL)
ALL is a fast-growing blood cancer that develops in the bone marrow and can spread to other body parts. ALL is rare, with 6,540 new cases diagnosed in the U.S. in 2023, affecting both children and adults. B-ALL, the most common type, begins in immature cells that develop into B-cell lymphocytes.
About BLINCYTO® (blinatumomab)
BLINCYTO is the first globally approved BiTE® immuno-oncology therapy targeting CD19 surface antigens on B cells. BiTE® molecules help the immune system detect and target cancer cells by engaging T cells to cancer cells, leading to their destruction.
BLINCYTO is approved in the U.S. for:
- CD19-positive B-ALL in adults and pediatric patients in the consolidation phase of therapy.
- CD19-positive B-ALL in first or second complete remission with MRD ≥ 0.1%.
- Relapsed or refractory CD19-positive B-ALL in adults and pediatric patients.
BLINCYTO® IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
Cytokine Release Syndrome (CRS): May be life-threatening or fatal. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
Neurological Toxicities: May be severe, life-threatening, or fatal. Interrupt or discontinue BLINCYTO® as recommended.
Contraindications: Known hypersensitivity to blinatumomab or any component of the product.
Warnings and Precautions: Monitor for CRS, neurological toxicities, infections, tumor lysis syndrome (TLS), neutropenia, febrile neutropenia, elevated liver enzymes, pancreatitis, leukoencephalopathy, and preparation and administration errors.
Adverse Reactions: Common adverse reactions include pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.
Dosage and Administration: Administered as a continuous intravenous infusion using a programmable, lockable infusion pump. Follow preparation and administration instructions strictly to minimize medication errors.
For full Prescribing Information, including BOXED WARNINGS, visit the BLINCYTO website.
