ASH Clinical News | Page 42

Calendar April 18 – 22, 2015 April 20 – 22, 2015 2015 American Association for Cancer Research Annual Meeting British Society of Hematology Annual Scientific Meeting Philadelphia, PA The AACR Annual Meeting 2015 will highlight the latest discoveries in every area of cancer research. This year’s meeting theme is “Bringing Cancer Discoveries to Patients.” Edinburgh, Scotland, UK The 55th Annual Scientific Meeting gathers the British hematology community to network and discuss the changing clinical and laboratory practice landscape, as well as report on advances in the field. The theme of this year’s meeting is “improving outcomes.” Philadelphia city scape as seen from the Benjamin Franklin Bridge Summary of Prescribing Information BLINCYTO™ (blinatumomab) for injection, for intravenous use WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES observed in approximately 25% of patients, some of which were life-threatening or fatal. As appropriate, administer prophylactic antibiotics and employ surveillance testing during treatment with BLINCYTO™. Monitor patients for signs and symptoms of infection and treat appropriately. 5.4 Tumor Lysis Syndrome • Cytokine Release Syndrome (CRS), which may be lifethreatening or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended. [See Dosage and Administration (2.3), Warnings and Precautions (5.1)]. • Neurological toxicities, which may be severe, lifethreatening, or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended. [See Dosage and Administration (2.3), Warnings and Precautions (5.2)]. Tumor lysis syndrome (TLS), which may be life-threatening or fatal, has been observed in patients receiving BLINCYTO™. Appropriate prophylactic measures, including pretreatment nontoxic cytoreduction and ontreatment hydration, should be used for the prevention of TLS during BLINCYTO™ treatment. Monitor for signs or symptoms of TLS. Management of these events may require either temporary interruption or discontinuation of BLINCYTO™ [see Dosage and Administration (2.3)]. 1. Neutropenia and febrile neutropenia, including lifethreatening cases, have been observed in patients receiving BLINCYTO™. Monitor laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO™ infusion. Interrupt BLINCYTO™ if prolonged neutropenia occurs. INDICATIONS AND USAGE BLINCYTO™ is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials [see Clin