The Food and Drug Administration approvedwho are in remission but still have minimal residual disease (MRD).
This is the first FDA-approved treatment for ALL patients with MRD.
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.
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.
Blinatumomab is marketed as Blincyto by Amgen.
FDA News Release: FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
This Week's Must Reads
Must Reads in ALL
Tisagenlecleucel responses persist at 18 months in r/r B-cell ALL, Grupp SA et al. ASH 2018, Abstract 895
Immune system changes play a role in AML relapse, Christopher MJ et al. N Engl J Med. 2018 Oct 31. doi: 10.1056/NEJMoa1808777.
CAR T-cell cost effectiveness in ALL, Whittington MD et al. JAMA Pediatr. 2018 Oct 8. doi: 10.1001/jamapediatrics.2018.2530
CAR T induced resistance in ALL, Ruella M et al. Nat Med. 2018 Oct 1. doi: 10.1038/s41591-018-0201-9
ALL complications carry cognitive risks, Cheung YT et al. JAMA Pediatr. 2018 Sep 24. doi:10.1001/jamapediatrics.2018.2500.