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FDA Approves Blinatumomab for Pediatric Acute Lymphoblastic Leukemia

Jason M. Broderick @jasoncology
Published: Thursday, Sep 01, 2016

Lia Gore, MD

Lia Gore, MD
The FDA has granted an accelerated approval to blinatumomab (Blincyto) for the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The multicenter, dose-finding, efficacy Study 205 trial accrued 93 patients aged <18 years with Ph- B-cell precursor ALL who were refractory, had relapsed at least twice, or relapsed after an allogeneic hematopoietic stem cell transplantation (HSCT). Following the phase I portion of the study, the recommended blinatumomab regimen proposed by an independent monitoring panel for phase II was stepwise dosing of 5/15-μg/m²/day.

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