Posted from: Monday, October 03, 2016 - 04:25 PM - Present

Blincyto Approved for Children

August 30, 2016 – The US FDA approved Amgen’s supplemental biologics license application (sBLA) for Blincyto® (blinatumomab). Blincyto is a bispecific CD19-directed CD3 T-cell engager that was first FDA approved in 2014 for treating adults who have Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) that has recurred or that is no longer responding to previous treatment. FDA now has approved it for children and teens with the same type of relapsed or refractory ALL. It is dosed by weight for patients who weigh at least 45kg (99 pounds), and by body surface area (BSA) for patients who weigh less. Blincyto is given on 42-day cycles infused through a continuous intravenous (IV) pump for 28 days, which is followed by 14 days with no drug. Patients should be treated in a healthcare facility for the first nine days of their first treatment cycles, and for the first two days of cycle two. Up to five cycles may be needed for a course of treatment. Labeling for Blincyto carries boxed warnings about potentially fatal neurological toxicity and cytokine release syndrome that it could cause. Additionally, its use may be associated with a number of other possibly severe side effects including infections, neutropenia, pancreatitis and tumor lysis syndrome. 


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Last Updated Monday, November 11, 2019 - 02:19 PM.