BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with (1) B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. (2) Relapsed or refractory B-cell precursor acute lymphoblastic leukemia
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Blinatumomab (trade name Blincyto) is a biopharmaceutical drug used as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab specifically targets the CD19 antigen present on B cells. In December 2014, it was approved by the US Food and Drug Administration under the accelerated approval program.
BLINCYTO®(blinatumomab) for injection, for intravenous use. Initial U.S. Approval: 2014
Generic Name: blinatumomab
For injection: 35 mcg of lyophilized powder in a single-dose vial for reconstitution
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For overseas patients, Blincyto (Blinatumomab) can be made available in Send your enquiry to find Blincyto (Blinatumomab) in China, Cambodia, Indonesia, Malaysia, the Philippines, Singapore, Thailand, Vietnam, Hong Kong. UAE Iraq, Iran, Saudi Arabia, Jordan, Mexico, Argentina, Brazil, Chile, Colombia, Peru, Venezuela. Europe – Romania, Switzerland, Georgia, Turkey, Italy, UK, Ukraine, Azerbaijan, Latvia, Poland, Slovakia. Russia CIS – Armenia, Kazakhstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan, Mongolia, Algeria, Mauritius, Uganda, Zimbabwe. Australia and New Zealand.
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