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Blinatumomab Approaches European Approval for MRD+ ALL

Jason M. Broderick @jasoncology
Published: Friday, Nov 16, 2018

David M. Reese, MD

David M. Reese, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of blinatumomab (Blincyto) for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD) of at least 0.1%.

Of 116 patients who received at least one dose of blinatumomab, 87 were in CR with hematologic recovery and baseline MRD >0.1%, including 61 patients in CR1, 25 in CR2 and 1 in CR3. Sixty-nine patients (79.3%; 95% CI, 70.4%-87.6%) achieved a complete MRD response within the first cycle.
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