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
Atovaquone associated with increased nocardiosis risk, Molina A et al. Acute Leukemia Forum 2018, Poster Session.
Add-on ibrutinib boosted response in relapsed multiple myeloma, Chari A et al. Leuk Lymphoma. 2018 Apr 4. doi: 10.1080/10428194.2018.1443337.
Adding statin boosted AML response rate, Advani AS et al. Leuk Res. 2018 Apr;67:17-20.
Venetoclax is effective in CLL that relapses after idelalisib, , Coutre S et al. Blood. 2018;131(15):1704-11
Pembrolizumab after cytarabine boosts AML response, Zeidner J et al. Acute Leukemia Forum 2018, Poster Session.
Must Reads in ALL (Acute Lymphoblastic Leukemia)
Best TKI options in ALL, Jabbour E et al. Clin Lymphoma Myeloma Leuk. 2018 18(4):257-65
Blinatumomab eliminates residual B-cell ALL, Gökbuget N et al. Blood. 2018 Apr 5;131(14):1522-31.
FDA approves Blincyto for minimal residual disease in ALL, 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
Harvest T cells before chemo for ALL, Barrett DM et al. AACR 2018, Abstract 1631
This Appears to Predispose Children to ALL , J Clin Oncol; ePub 2018 Jan 4; Qian, Cao, et al