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
Observational study shows hydroxyurea well tolerated in sickle cell disease, Dauvergne B et al. FSCDR 2018, presentation JSCDH-D-18-00052
CAVEAT shows venetoclax plus chemo appropriate for older, fit AML patients , Wei AH et al. EHA Congress, Abstract S1564.
Large cohort study demonstrates DOAC safety vs. warfarin , Vinogradova Y et al. BMJ 2018;362:k2505.
Patients who develop AML may have detectable mutations years earlier, Desai P et al. Nat Med. 2018;24:1015-23.
Oral administration of arsenic + ATRA effective for APML, Zhu HH et al. Lancet Oncol. 2018;19:871-9.
Must Reads in ALL (Acute Lymphoblastic Leukemia)
ALL patients' liver toxicities linked to antibiotics, other therapies, Minetto P et al. EHA Congress (annual meeting of the European Hematology Association), Abstract PS934.
Patient-specific risk factors for BCC, SCC examined in study, Scott J et al. Presentation at American College of Mohs Surgery, May 2018.
Getting to MRD in ALL boosted survival, Hay KA. ASCO 2018 (annual meeting of the American Society of Clinical Oncology), Abstract 7005.
Pediatric cancers rising, Siegel DA et al. ASPHO 2018, Abstract 605.
In T-ALL, methotrexate and nelarabine boosted chemo response, Dunsmore KP et al. ASCO 2018, Abstract 10500.