The Food and Drug Administration has granted accelerated approval to blinatumomab for treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD).
This is the first FDA-approved treatment for those with MRD, the FDA said in a statement .
Blinatumomab was first approved in 2014 for the treatment of Philadelphia chromosome (Ph)-negative relapsed or refractory positive B-cell precursor ALL, and the indication expanded to include patients with Philadelphia chromosome–positive ALL in 2017.
The current approval was based on a single-arm clinical trial of 86 patients in first or second complete remission who had detectable MRD in at least 1 out of 1,000 cells in their bone marrow. Undetectable MRD was achieved by 70 patients after one cycle of blinatumomab treatment. More than half of the patients remained alive and in remission for at least 22.3 months, the FDA said.
Common side effects include bacterial and pathogen-unspecified infections, pyrexia, headache, infusion-related reactions, neutropenia, anemia, febrile neutropenia, and thrombocytopenia. The drug carries a boxed warning about cytokine release syndrome at the start of the first treatment. The FDA also warns that children weighing less than 22 kg should receive the drug prepared with preservative-free saline because of the risk of serious adverse reactions in pediatric patients from a benzyl alcohol preservative.
Blinatumomab is marketed as Blincyto by Amgen.