The U.S. Food and Drug Administration (FDA) expanded the indication of the bispecific antibody blinatumomab to include patients with B-cell precursor acute lymphocytic leukemia (ALL) who test positive for minimal residual disease (MRD).
The decision was based on results from a single-arm clinical trial that included 86 patients in first or second complete remission who had detectable MRD (present in ≥1 out of 1,000 cells in their bone marrow). Treatment with blinatumomab led to 70 patients achieving undetectable MRD levels, and more than half of these patients remained alive and in remission for at least 22.3 months.
Adverse events (AEs) in this trial were “consistent with those seen in other uses of the drug,” according to the FDA’s press release announcing the approval. Common AEs included infections, fever, headache, infusion-related reactions, neutropenia, anemia, and thrombocytopenia.
Blinatumomab is already approved for patients with relapsed or refractory B-cell precursor ALL.
Sources: Reuters, March 29, 2018; FDA press release, March 29, 2018.