How a Breakthrough Leukemia Drug is Shaping the Future of Bispecific T-Cell Therapies

01/12/2015 - 3 minutes

Blincyto (Blinatumomab) is the first bispecific antibody construct from Amgen’s BiTE proprietary platform to be granted clinical and regulatory validation so far…

amgen-logoAfter the acquisition in 2012 of Micromet, the Munich-based company that first developed Blinatumomab, Amgen kept revealing the potential of this powerful protein… Blincyto was then approved by the FDA as an orphan drug in December last year for use in Philadelphia chromosome-negative (Ph-) precursor B-cell Acute Lymphoblastic Leukemia (ALL).

Used as a monotherapy to treat this ultra-rare form of blood cancer, it showed a complete remission within two cycles of treatment in a clinically meaningful number of target patients. Amgen is now moving a step further, and getting closer to approval of the drug in Europe…

Blincyto has been granted positive CHMP (Committee for Medicinal Products for Humans) opinion in September, following results of two Phase II trials (MT103-206 and 211) for adults application. The evaluation of the drug by the CHMP is a preliminary step to approval by the EMA.

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