A supplemental biologics license application has been submitted to the U.S. Food and Drug Administration (FDA) to expand blinatumomab’s approval to include the treatment of children with Ph− relapsed/refractory B-cell precursor acute lymphocytic leukemia (ALL).
The application is based on the results of a single-arm, multi-center, dose-finding, phase I/II study that examined the efficacy of blinatumomab in patients aged 18 years or younger with Ph− B-cell precursor ALL who were refractory, had relapsed at least twice, or relapsed after an allogeneic hematopoietic cell transplantation. All patients in the trial have completed therapy and are being observed for long-term outcomes. Early results have shown that blinatumomab has induced complete remissions in some pediatric patients, according to the drug’s manufacturer, though the exact overall response rate has not been released.
The most common serious adverse events (AEs) associated with blinatumomab included pyrexia, febrile neutropenia, cytokine release syndrome, sepsis, device-related infection, overdose, convulsion, respiratory failure, hypoxia, pneumonia, and multi-organ failure. The researchers reported that these serious AEs are comparable to those reported in previous clinical trials of blinatumomab.
The FDA previously granted blinatumomab accelerated approval for the treatment of adults with ALL in December 2014.
Source: Amgen press release, March 3, 2016.