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
ALL patients' liver toxicities linked to antibiotics, other therapies, Minetto P et al. EHA Congress (annual meeting of the European Hematology Association), Abstract PS934.
Thrombocytopenia in pregnancy raises risk of complications, Reese J et al. N Engl J Med. 2018;379:32-43.
Escalating venetoclax dose was safe in relapsed CLL, Koenig K et al. EHA Congress (annual meeting of the European Hematology Association), Abstract PF357.
PET findings safely drive chemo decisions in Hodgkin lymphoma patients, Casasnovas O et al. ASCO 2018 (annual meeting of the American Society of Clinical Oncology), Abstract 7503.
Hydroxyurea tolerated well in sickle cell patients, Dauvergne B et al. FSCDR 2018 (annual meeting of the Foundation for Sickle Cell Disease Research), presentation JSCDH-D-18-00052.