FDA approves supplemental application for Blincyto (blinatumomab) in Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia- Amgen

Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include overall survival (OS) data from the Phase III TOWER study in the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval converts Blincyto's accelerated approval to a full approval. The sBLA approval also included data from the Phase II ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. The approval is based on results from the TOWER study, which found that Blincyto demonstrated a superior improvement in median OS over standard of care (SOC) chemotherapy, nearly doubling median OS. The study showed that median OS was 7.7 months (95 percent CI: 5.6, 9.6) for Blincyto versus four months (95 percent CI: 2.9, 5.3) for SOC (hazard ratio for death=0.71; p=0.012). The approval is also based on data from the Phase II ALCANTARA study, which evaluated the efficacy of Blincyto in adult patients with Ph+ relapsed or refractory B-cell precursor ALL.

Comment: Blincyto was granted breakthrough therapy and priority review designations by the FDA, and is 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 granted conditional marketing authorization in the European Union for the treatment of adults with Ph- relapsed or refractory B-precursor ALL.