Blincyto

B-cell precursor acute lymphoblastic leukemia (ALL) — relapsed or refractory; Philadelphia chromosome-negative, CD19-positive, in first or second complete remission with minimal residual disease (MRD) ≥0.1%; Newly diagnosed Philadelphia chromosome-positive in combination with a TKI

Relapsed/refractory ALL (≥45 kg): Cycle 1: 9 mcg/day continuous IV infusion Days 1-7, then 28 mcg/day Days 8-28; subsequent cycles: 28 mcg/day Days 1-28 followed by 14-day treatment-free interval
MRD-positive ALL: Same dosing as relapsed/refractory
Continuous IV infusion over 24 hours (infusion bags changed every 24, 48, 72, or 96 hours)
Hospitalization: Recommended for first 9 days of Cycle 1 and first 2 days of Cycle 2
Pre-medication: Dexamethasone 20 mg IV 1 hour before each cycle start, before step dose, and upon restarting after ≥4-hour interruption

For injection: 35 mcg lyophilized powder in single-dose vial (with IV solution stabilizer)

None listed.

• CRS: 15% (2.4% Grade ≥3). Median time to first event: 2 days. Manage with corticosteroids; withhold or discontinue as indicated.
• Neurological Toxicities: 65% (13% Grade ≥3). Including tremor, dizziness, confusion, encephalopathy, aphasia, seizures (2-5%), cranial nerve disorders. Median time to first event: within first 2 weeks.
• Infections: 34% (20% Grade ≥3). Including sepsis (12%), pneumonia (10%). Fatal infections reported.
• Tumor Lysis Syndrome: Pre-treat with hydration and anti-hyperuricemics for high tumor burden patients.
• Neutropenia and Febrile Neutropenia: 16% febrile neutropenia.
• Effects on Driving and Using Machines: Due to neurological events. Advise against driving.
• Pancreatitis: Including fatal cases. Evaluate clinically significant abdominal pain.
• Preparation and Administration Errors: Follow instructions carefully. Errors have occurred.
• Leukoencephalopathy: Including PML-compatible findings.

Pyrexia (62%), headache (36%), infections (34%), infusion-related reactions (30%), nausea (25%), tremor (20%), edema (16%), febrile neutropenia (16%), constipation (15%), anemia (15%), diarrhea (14%), fatigue (13%)

CRS in 15% (Grade 3+ in 2.6%). Neurologic toxicity in 65% (Grade 3+ in 13%) including encephalopathy, seizures, and cerebral edema.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 15% (Grade 3+ in 2.6%). Neurologic toxicity in 65% (Grade 3+ in 13%) including encephalopathy, seizures, and cerebral edema.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Blinatumomab is a bispecific T-cell engager (BiTE) antibody construct consisting of two single-chain variable fragments (scFvs) — one binding CD19 on B cells and one binding CD3 on T cells. By simultaneously bridging T cells and CD19-positive B cells, it activates endogenous T cells to release perforin and granzymes, inducing apoptosis and lysis of CD19-positive target cells independent of MHC restriction or T-cell receptor specificity.

Estimated half-life: 2.1 hours. Steady-state serum concentration (Css) reached within 1 day of continuous IV infusion. Clearance: 3.1 L/h. Vd: 4.4 L. Not expected to be metabolized by CYP enzymes.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• TOWER — Blinatumomab vs. standard chemo in relapsed/refractory B-ALL. Phase III, n=405.
  🔬 NCT02013167 ↗ 📄 Primary Publication ↗

Blincyto has FDA-approved indications across the following cancer types covered on PipelineEvidence: