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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

The Food and Drug Administration approved blinatumomab for the 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 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.

Read the news release.

Citation:

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

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Gene sequencing bone marrow in myelodysplastic syndrome, Duncavage EJ et al. N Engl J Med 2018;379:1028-41.

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Genetic markers signal poor prognosis in MCL, Obr A et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 23. doi: 10.1016/j.clml.2018.07.282

Disparities in ALL treatment toxicity, Taylor OA et al. Clin Cancer Res. 2018 Sep 11. doi: 10.1158/1078-0432.CCR-18-0939

Leukemia risk after maternal contraception use, Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0

Must Reads in ALL (Acute Lymphoblastic Leukemia)

Levofloxacin prophylaxis in ALL, AML , Alexander S, et al. JAMA. 2018;320(10):995-1004

Disparities in ALL treatment toxicity, Taylor OA et al. Clin Cancer Res. 2018 Sep 11. doi: 10.1158/1078-0432.CCR-18-0939

Leukemia risk after maternal contraception use, Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0

Methotrexate escalation in T-cell ALL, Winter SS et al. J Clin Oncol. 2018 Aug 23. doi: 10.1200/JCO.2018.77.7250.

ALL patients are not routinely getting appropriate IT MTX , Sommerfeld SA et al. EHA Congress, Abstract PS930.