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Medicine OK’d for Some Kids and Adults with ALL

June 14, 2024

The FDA has OK’d blinatumomab (Blincyto; Amgen) for patients who are at least one month old with CD19-positive Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. Efficacy was evaluated in two trials: Study E1910 and Study 20120215. In the former, 224 patients received either a consolidation regimen comprised of multiple blinatumomab monotherapy cycles plus multiple cycles of intensive chemotherapy or intensive chemotherapy alone. The 3-year overall survival (OS) rates were 84.8% and 69%, respectively. In Study 20120215, 111 children and young adults with the disease received either blinatumomab or a combination of intensive chemotherapies. The 5-year OS was 78.4% and 41.4%, respectively; the 5-year relapse-free survival was 61.1% and 27.6% respectively.

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