ASH Clinical News January 2016 | Page 14

The largest prospective study in
Ph- relapsed or refractory B-cell
precursor ALL published to date 2
In a phase 2, open-label, multicenter, single-arm clinical trial
• The primary endpoint was the complete remission/
complete remission with partial hematological
recovery (CR/CRh*) rate within 2 cycles of treatment
with BLINCYTO®.
• Eligible patients were ≥ 18 years of age with
Philadelphia chromosome-negative relapsed or
refractory B-cell precursor ALL.

• Relapsed or refractory was defined as relapsed with
first remission duration of ≤ 12 months in first salvage
or relapsed or refractory after first salvage therapy or
relapsed within 12 months of allogeneic hematopoietic
stem cell transplantation (HSCT), and had ≥ 10% blasts
in bone marrow.

Clinically significant single-agent activity demonstrated in pivotal study1
IMPORTANT SAFETY INFORMATION
Contraindications
BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any
component of the product formulation.

Warnings and Precautions
• Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO®. Infusion
reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients
for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine
aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated
intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage
activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO® as outlined in the Prescribing Information (PI).
• Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO® in clinical trials experienced neurological
toxicities. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 15% of patients, including
encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and
coordination and balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor patients
for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
• Infections: Approximately 25% of patients receiving BLINCYTO® experienced serious infections, some of which were lifethreatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment.
Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of
BLINCYTO® as needed.
• Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS has been observed. Preventive measures, including pretreatment
nontoxic cytoreduction and on treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and
symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
• Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate
laboratory parameters during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
• Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving
BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous
occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
References: 1. BLINCYTO® (blinatumomab) US prescribing information, Amgen. 2. Topp M, Gökbuget N, Stein AS, et al. Safety and activity of blinatumomab for
adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16:57-66.

BLINCYTO® is a registered trademark of Amgen Inc.
© 2015 Amgen Inc. All rights reserved. USA-103-113482 11/15