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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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