FDA Approves Blincyto for B-Cell Precursor ALL in Remission With MRD Presence
This FDA approval makes blinatumomab the first approved treatment for patients with MRD-positive ALL.
The Food and Drug Administration (FDA) has granted accelerated approval and Priority Review to Blincyto (blinatumomab; Amgen) for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). Patients in remission with MRD presence may have a higher risk of relapse.
The accelerated approval marks Blincyto, a bispecific CD19-directed CD3 T-cell engager, as the first approved treatment for patients with MRD-positive ALL. It is already approved to treat relapsed or refractory B-cell precursor ALL. Additional data from randomized controlled trials are needed to confirm that achieving undetectable MRD with Blincyto improves survival or disease-free survival in patients with ALL.
A single-arm trial (N=86) evaluated Blincyto in ALL patients in first or second complete remission with detectable MRD in at least 1 of 1,000 cells in their bone marrow. Efficacy was measured according to achievement of undetectable MRD in an assay that could detect at least 1 cancer cell in 10,000 cells following 1 cycle of Blincyto; hematological relapse-free survival was also measured. The data showed 70 patients achieved undetectable MRD and more than 50% survived in remission for at least 22.3 months.
Common adverse effects include infections, pyrexia, headache, infusion related reactions, neutopenia, anemia, febrile neutropenia, and thrombocytopenia.
Blincyto is available as a 35mcg strength lyophilized powder for intravenous (IV) infusion after reconstitution.
For more information call (800) 772-6436 or visit FDA.gov.