FDA OKs Blinatumomab for Children, Adults with CD-19 B-ALL in Consolidation Phase

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The FDA approved blinatumomab for patients 1 month or older with CD19-positive, Philadelphia chromosome–negative, B-cell precursor acute lymphoblastic leukemia.

The FDA approved blinatumomab (Blincyto) for adults and pediatric patients aged 1 month or older with CD19-positive, Philadelphia chromosome–negative, B-cell precursor acute lymphoblastic leukemia in the consolidation phase, irrespective of measurable residual disease status.

The decision is supported by data from the phase 3 E1910 study, in which the addition of blinatumomab to multiphase consolidation chemotherapy (n = 112) resulted in a superior overall survival (OS) benefit vs chemotherapy alone (n = 112), with 3-year OS rates of 84.8% and 69%, respectively. At a median follow-up of 4.5 years, the respective 5-year OS rates were 82.4% and 62.5%, respectively.

"In the E1910 study, blinatumomab reduced risk of death and showed a remarkable improvement in overall survival," Selina M. Luger, MD, professor of hematology-oncology at the University of Pennsylvania's Perelman School of Medicine and Abramson Cancer Center, chair of the ECOG-ACRIN Leukemia Committee, and study investigator, stated in a press release. "This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone."

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