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Blincyto Receives Expanded Approval From FDA

April 2, 2018

The FDA granted accelerated approval for Amgen’s Blincyto (blinatumomab) to treat children and adults with B-cell precursor acute lymphoblastic leukemia who are at risk of relapse.

The approval — FDA’s first for an MRD-positive ALL treatment — includes patients who have achieved remission from initial treatment for ALL but still have minimal residual disease.

Blincyto’s effectiveness was displayed in a single-arm clinical trial, and its side effects are consistent with those seen in other uses of the drug.

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