www.fdanews.com/articles/186229-blincyto-receives-expanded-approval-from-fda
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.