SBLA submitted to FDA for Blincyto (blinatumomab) in pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia- Amgen

Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The sBLA is based on data from the Phase I/II '205 single-arm trial, which found that treatment with Blincyto induced complete remission in a clinically meaningful number of pediatric patients with Ph- relapsed or refractory B-cell precursor ALL. Overall, the types of serious adverse events (AEs) reported in the pediatric population are consistent with the known Blincyto safety profile. The FDA approved prescribing information for Blincyto includes a boxed warning for cytokine release syndrome and neurologic toxicities.

Comment: Blincyto was granted breakthrough therapy and priority review designations by the FDA, and is now approved in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials. Blincyto was also recently granted conditional marketing authorization in the European Union for the treatment of adults with Ph- relapsed or refractory B-precursor ALL.