Amgen wins full approval for leukemia therapy Blincyto
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Amgen (NASDAQ:AMGN) announced Wednesday that the U.S. FDA converted the accelerated approval for its blood cancer therapy Blincyto to a full approval, allowing its use as a regular treatment for certain patients with B-cell precursor acute lymphoblastic leukemia (B-ALL).
Considering new data from two Phase 3 trials, the FDA issued full approval for Blincyto for adults and children with minimal residual disease (MRD)-positive B-ALL, the Thousand Oaks, California-based company said.

In 2018, the FDA granted accelerated approval for the CD19-directed T-cell engager in MRD-positive B-ALL.
In 2017, the agency issued full approval for Blincyto as an intravenous infusion for adults and children with relapsed or refractory CD19-positive B-ALL.

A study for a subcutaneous version of Blincyto is currently underway at Amgen (AMGN) in addition to its trials aimed at MRD-negative B-ALL patients.


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